By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionBuild a stable career. Support your family. Help save lives.Are you looking for more than “just a job”? At Takeda, the work you do every day directly helps patients living with severe and chronic diseases. As a Manufacturing Technician II, you’ll assist in producing lifesaving and life-sustaining therapies that families around the world rely on—while building a stable, long-term career with excellent benefits and real growth opportunities.
If you have GMP manufacturing experience and are ready for a stable role with purpose, this might be the opportunity you’ve been searching for.
This role works on a 2-2-3 rotating shift with working hours from 5:00 PM to 5:30 AM.
Why this role mattersEvery batch you help produce can mean saving a trauma patient, improving quality of life, and bringing renewed hope to patients and their loved ones. You are not just running equipment—you’re playing a critical role in making high-quality therapies available to people who depend on them every single day.
In this role, you will: Run and support production activities in accordance with cGMP, safety, and quality standards while operating key equipment such as DAP lines, forklifts, hoists, and moving products and materials through the production process.Lead the line, train junior technicians, and collaborate with other teams to achieve production and quality goals.Accurately complete batch documentation, keep your work area clean and ready for inspection, and promptly report safety, quality, or equipment issues to management.What we offer you:We understand that caring for patients begins with caring for our team. As a Manufacturing Technician II at Takeda, you can expect:
Stable, dependable employment: A full-time position with a reputable, global pharmaceutical leader.Competitive pay: Your GMP experience is valued and rewarded with industry-leading compensation.Outstanding benefits for you and your family: Comprehensive health coverage, paid time off, retirement contributions, tuition assistance, and other perks designed to support your life both inside and outside of work.Career growth and development: Clear opportunities to advance, learn new skills, and move into higher-level roles—your growth is integrated into our plan.Flexible shifts that support your life: Night shift is available with our employee-friendly 2-2-3 rotating schedule, allowing you to plan around family and personal commitments. You must also be able to support a 24/7 manufacturing operation as needed, including overtime, weekends, holidays, and 12-hour shifts.A safe, supportive team environment: Work in a modern, clean facility with a team that looks out for one another and takes pride in doing things the right way.What you bring:We’re looking for people who take pride in their work and want a long-term career home.
GMP manufacturing experience is requiredHigh school diploma or GED required (associate’s degree or higher preferred)At least 2 years of related experience, or 1 year with an AA degreeAbility to speak, read, write, and follow work instructions in EnglishImportant Considerations:At Takeda, our patients rely on us to deliver safe, high-quality medicines, and we prioritize the health and safety of our employees. In this role, you may:
Able to carry, lift, and push/pull up to 30 lbs. (with material handling equipment when needed)Able to stand and walk for most of a 12-hour shift, including moving between rooms and across the siteComfortable bending, twisting, reaching overhead, squatting, and doing repetitive hand and arm motionsWork indoors around moving equipment and machinery, with some loud noise (hearing protection may be required)Work around chemicals such as alcohol, acids, buffers, and Celite (respiratory protection may be required)Work in controlled areas that require special safety gear and gowning, including protective clothing to cover the head, face, hands, feet, and bodyMay work in clean rooms and cool or hot storage areas, depending on departmentMust not be allergic to cephalosporin for specific product-touch rolesMust follow appearance rules in manufacturing areas (for example, no make-up, jewelry, nail polish, or artificial fingernails in designated areas)Able to work flexible or non-traditional hours to support 24/7 operations, including some overtime, weekends, holidays, and off-shift coverageMore About Us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1 #LI-MA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IL - Round Lake - Drug DeliveryU.S. Hourly Wage Range:
$19.81 - $31.10
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
No Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:Takeda is seeking a Production Operations Group Lead to supervise activities in the initial inspection, pasteurization, and incubator production areas at our Round Lake, Illinois manufacturing facility. Reporting to the Associate Manager, this role is responsible for ensuring manufacturing goals are achieved while maintaining compliance with cGMP, EHS, and other applicable regulatory requirements. You will drive the efficient use of raw materials, equipment, and workforce resources to deliver high-quality products safely and effectively.
This role is assigned to Night Shift (A/B – 5:00 a.m.–5:30 p.m.) on a 2-2-3 rotating schedule.
How you will contribute:Monitor labor and capital spending. Recommend improvements to manufacturing policies, procedures, and programs.Provide guidance, support, and leadership through positive daily interactions with employees.Supervise daily production, scheduling, staffing, material management, compliance, training, and audits to meet deadlines and quality standards.Review and approve batch and system records. Support product release timing goals.Ensure staff complete training on time and follow manufacturing processes in compliance with cGMP and EHS requirements.Lead simple process improvement projects. Provide manufacturing input for new equipment and process integration and validation.Resolve technical, material, and cGMP issues that may affect deadlines. Provide troubleshooting support during process deviations.Represent the company during FDA inspections.Conduct daily gemba walks to support employee engagement and reinforce safety and GMP practices.Apply lean manufacturing principles in simple situations with ongoing coaching.Conduct basic auditing tasks under supervision.Troubleshoot simple problems with ongoing coaching.What you bring to Takeda:High School Diploma or GED with 5+ years of related experience; or a bachelor’s degree in science or engineering, or a related technical field with 2+ years of related experienceAbility to work effectively across departments and contribute to team leadership in a collaborative environment.Strong verbal and written communication, teamwork, and documentation skills, with a focus on customer service and safe performance under pressure.Understanding of cGMP and other regulatory requirements relevant to the pharmaceutical or medical industry.Understanding and can apply key concepts of Continuous Improvement Process with support.Proficient in MS Word, MS Excel.Experience working in an FDA regulated environment preferred.Important Considerations:At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.Work in a cold, wet environment.Work multiple shifts, including weekends and holidays, or be asked to work supplemental hours, as necessary.Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.Must be willing and able to work aligned shift.Must be able to carry up to 30 lbs., lift up to 30lbs, push/pull up to 30lbs (with assistance of material handling equipment).Must be able to stand and/or walk for an extended period over an 8–12-hour shift between rooms and across the site.Indoor working conditions.Will work around moving equipment and machinery.May be required to work in a confined area.Some Clean Room and cool/hot storage conditionsMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
INT_2026
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IL - Round Lake - Drug DeliveryU.S. Base Salary Range:
$71,800.00 - $112,860.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
Yes Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
POSITION OBJECTIVES:
Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.
As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project.
Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Possesses primary responsibility for dosage selection and generation of causality evidence.
Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.
Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data and Quantitative Sciences (DQS) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.
POSITION ACCOUNTABILITIES:
Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams.
Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).
Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions.
Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions.
Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DQS and external partners.
Maintains a high standard for good clinical practice, compliance, and ethics.
Provides mentorship to junior staff, acts as a cross functional leader and may manage a sub-team within a TA.
Participates as a member of Business Development due diligence, when requested.
Leads infrastructure initiatives and/ or cross-functional best practice initiatives.
Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Desired education qualifications and equivalencies and desired minimum years industry experience:
Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD
MS with 12+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD
Desired technical skills:
Extensive knowledge and experience with design, analysis, and reporting of clinical pharmacology studies.
Specialized clinical pharmacology expertise in multiple therapeutic areas, development phases, and/or different regions.
Experience in leading and driving the scoping and implementation of MIDD within projects.
Hands-on expertise/knowledge in application of advanced knowledge in integration of multiple data sources (PK/PD/Efficacy/Safety/biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial design, and quantitative decision making.
Experience in regulatory submission and approvals of at least one original/major NDA/CTDs or multiple supplemental NDA/CTDs (global or regional).
Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant development milestones such as EoP2, pre-submission, and pediatric development plan (PIP and PWR).
Strong knowledge of allied fields critical for drug development, such as statistics, drug metabolism, pharmacology, toxicology, bioanalysis, and pharmaceutical science.
Ability to evaluate Benefit-Risk associated with project decisions, effectively manage GPT expectations and influence TA strategies.
Leadership in cross functional decision to optimize the likelihood of drug R&D success and utilization of the quantitative decision-making framework.
Drives efficiency using innovative processes and methodologies.
Accelerates regional development and filings through innovation (regional QCP).
Desired behavioral competencies:
Independently executes QCP deliverables and provides solutions to complex issues.
Consistently delivers with high quality and efficiency.
Elevates knowledge and enhances the capability of others.
Communicates effectively and influences in cross-functional teams.
Inspires commitment and enables cross-function collaboration.
Communicates success stories and shares learning across QCP.
Focuses on priorities and delivers on commitments.
This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
#LI-JV2
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MAU.S. Base Salary Range:
$177,000.00 - $278,080.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
GOALS:
Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s):
Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.
ACCOUNTABILITIES:
Accountable for planning and operational strategy and execution for assigned clinical trials.Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.Challenges study team to ensure operational feasibility, inclusive of patient and site burdenValidates budget and ensures impacts are adequately addressed.Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.Challenges study team to ensure timelines meet the needs of the clinical development plan.Ensure new team members and vendors are appropriately onboarded.During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs.Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.Specific areas of sponsor oversight include, but are not limited to:Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoringReview and endorsement of relevant study plans, as applicableStudy team meeting management and attendance when necessary; regular review of meeting agendas and minutesReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the studyDocumented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategiesIn partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.Ensure studies are “inspection ready” at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections.Represent the Lead Clinical Study Manager role in functional initiatives or working groups. Help with onboarding and mentoring of new or junior CSMs.May assist the program COPL in his/her role, as requiredEDUCATION AND EXPERIENCE:
BS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.Demonstrated excellence in project/program management and matrix leadership.Excellent communication skills.Excellent teamwork, organizational, interpersonal, and problem-solving skills.Fluent business English (oral and written).TRAVEL REQUIREMENTS:
Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
$116,000.00 - $182,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.#LI-Remote
Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team.At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
GOALS:
Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s):
Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned.
ACCOUNTABILITIES:
Accountable for planning and operational strategy and execution for assigned clinical trials.Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.Challenges study team to ensure operational feasibility, inclusive of patient and site burdenValidates budget and ensures impacts are adequately addressed.Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.Challenges study team to ensure timelines meet the needs of the clinical development plan.Ensure new team members and vendors are appropriately onboarded.During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs.Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.Specific areas of sponsor oversight include, but are not limited to:Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoringReview and endorsement of relevant study plans, as applicableStudy team meeting management and attendance when necessary; regular review of meeting agendas and minutesReview of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the studyDocumented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategiesIn partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.Ensure studies are “inspection ready” at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections.Represent the Lead Clinical Study Manager role in functional initiatives or working groups. Help with onboarding and mentoring of new or junior CSMs.May assist the program COPL in his/her role, as requiredEDUCATION AND EXPERIENCE:
BS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.Demonstrated excellence in project/program management and matrix leadership.Excellent communication skills.Excellent teamwork, organizational, interpersonal, and problem-solving skills.Fluent business English (oral and written).TRAVEL REQUIREMENTS:
Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
$116,000.00 - $182,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.#LI-Remote
Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
GOALS:
Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.
In close collaboration with Clinical Operations Program Lead(s):
Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
The assigned clinical studies may be of low to medium level of complexity. More than one study and/or more than one program may be assigned.
ACCOUNTABILITIES:
Accountable for planning and operational strategy and execution for assigned clinical trials.
o Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.
o Challenges study team to ensure operational feasibility, inclusive of patient and site burden.
o Validates budget and ensures impacts are adequately addressed.
o Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy.
o Challenges study team to ensure timelines meet the needs of the clinical development plan.
o Ensure new team members and vendors are appropriately onboarded.
During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place.
Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly.
Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs.
Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.
Specific areas of sponsor oversight include, but are not limited to:
o Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring.
o Review and endorsement of relevant study plans, as applicable.
o Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes.
o Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study.
o Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies.
In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
EDUCATION AND EXPERIENCE:
BS/BA required, preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience.
Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements.
5 or more years’ experience in pharmaceutical industry and/or clinical research organization, including 3 or more years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA).
Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.
Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
Demonstrated successful experience in project/program management and matrix leadership.
Good communication skills.
Excellent teamwork, organizational, interpersonal, and problem-solving skills.
Fluent business English (oral and written).
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - VirtualU.S. Base Salary Range:
$103,500.00 - $162,690.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.#LI-Remote
Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionBuild a stable career. Support your family. Help save lives.At Takeda’s Round Lake site, the work you do every day helps patients living with severe and chronic diseases. As a Maintenance Technician II, you’ll keep our Mix, Fill, and Finishing operations running smoothly in our Drug Delivery facility - keeping critical manufacturing lines running so lifesaving and life-sustaining therapies can reach families around the world.
This is a hands-on role for someone who takes pride in reliability, safety, and solving problems fast—especially when production depends on it.
The hours for this role is 6:00PM – 6:30AM working on a 2-2-3 rotating shift.
Why this role mattersWhen equipment runs the way it should, patients get the therapies they’re counting on. You’ll help ensure lines are maintained and production-ready, complete preventative maintenance on time, and stay engaged during runs to spot and resolve issues before they impact quality or output. Your troubleshooting skills repairing mechanical, electrical, pneumatic, and hydraulic systems will directly support consistent, high-performing operations in a GMP environment.
In this role, you will: Keep production equipment reliable and ready to run: Maintain filling lines and related equipment, monitor performance during production, and partner with Manufacturing to reduce downtime.Perform preventive maintenance and documentation: Review/prepare PMs (including parts verification), execute PMs on time, complete required records, and use JDE CMMS to initiate/track work orders and downtime.Troubleshoot, repair, and improve equipment performance: Diagnose and repair mechanical, electrical, pneumatic, hydraulic, and robotic systems; rebuild assemblies; analyze trends to eliminate recurring issues; escalate to Leads/Engineering when needed.Work safely, compliantly, and develop others: Follow corporate specs/SOPs and GMP expectations, lead by example on safe work practices (Stop & Fix), report unsafe conditions, complete all required training on time, and train/mentor less experienced technicians.What you bring to Takeda:We’re looking for people who take pride in their work and want a long-term career home.
High school diploma/GED with 2+ years of related experience, or an Associate’s degree (or higher) with 1+ year; technical certifications a plus (3+ years manufacturing systems experience preferred).Prior experience in an FDA-regulated/GMP environment preferred, with strong documentation practices and attention to detail.Experience with electrical, mechanical, hydraulic, and pneumatic systems, and the ability to read/interpret electrical, mechanical, and pneumatic drawings (PLC knowledge or willingness to learn).Proficient with MS Word/Excel and JDE (or similar CMMS)Important Considerations:At Takeda, our patients rely on us to deliver safe, high-quality medicines, and we prioritize the health and safety of our employees. In this role, you may:
Able to work flexible or non-traditional hours to support 24/7 operations, including some overtime, weekends, holidays, and off-shift coverageWork in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. (Removing all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment). Indoor working conditions and exposure to loud noises that require hearing protection.Work in a cold, wet environment.Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.Must be able to carry up to 100lbs, lift up to 100lbs, push/pull up to 100lbs, with assistance of material handling equipment and/or two-person lifts.Must be able to stand and/or walk for an extended period over an 8-12 hour shift between rooms and across the site.May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.Will work around moving equipment and machinery.May be required to work in confined spaces/areas.May be exposed to and must not be allergic to cephalosporin.May require immunization before performing work within the manufacturing area.Travel up to 5%More About Us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1 #LI-1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IL - Round Lake - Drug DeliveryU.S. Hourly Wage Range:
$19.81 - $31.10
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
No Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:Takeda is seeking a Production Operations Group Lead to supervise activities in the initial inspection, pasteurization, and incubator production areas at our Round Lake, Illinois manufacturing facility. Reporting to the Associate Manager, this role is responsible for ensuring manufacturing goals are achieved while maintaining compliance with cGMP, EHS, and other applicable regulatory requirements. You will drive the efficient use of raw materials, equipment, and workforce resources to deliver high-quality products safely and effectively.
This role is assigned to Night Shift (C/D – 5:00 p.m.–5:30 a.m.) on a 2-2-3 rotating schedule.
How you will contribute:Monitor labor and capital spending. Recommend improvements to manufacturing policies, procedures, and programs.Provide guidance, support, and leadership through positive daily interactions with employees.Supervise daily production, scheduling, staffing, material management, compliance, training, and audits to meet deadlines and quality standards.Review and approve batch and system records. Support product release timing goals.Ensure staff complete training on time and follow manufacturing processes in compliance with cGMP and EHS requirements.Lead simple process improvement projects. Provide manufacturing input for new equipment and process integration and validation.Resolve technical, material, and cGMP issues that may affect deadlines. Provide troubleshooting support during process deviations.Represent the company during FDA inspections.Conduct daily gemba walks to support employee engagement and reinforce safety and GMP practices.Apply lean manufacturing principles in simple situations with ongoing coaching.Conduct basic auditing tasks under supervision.Troubleshoot simple problems with ongoing coaching.What you bring to Takeda:High School Diploma or GED with 5+ years of related experience; or a bachelor’s degree in science or engineering, or a related technical field with 2+ years of related experienceAbility to work effectively across departments and contribute to team leadership in a collaborative environment.Strong verbal and written communication, teamwork, and documentation skills, with a focus on customer service and safe performance under pressure.Understanding of cGMP and other regulatory requirements relevant to the pharmaceutical or medical industry.Understanding and can apply key concepts of Continuous Improvement Process with support.Proficient in MS Word, MS Excel.Experience working in an FDA regulated environment preferred.Important Considerations:At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.Work in a cold, wet environment.Work multiple shifts, including weekends and holidays, or be asked to work supplemental hours, as necessary.Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.Must be willing and able to work aligned shift.Must be able to carry up to 30 lbs., lift up to 30lbs, push/pull up to 30lbs (with assistance of material handling equipment).Must be able to stand and/or walk for an extended period over an 8–12-hour shift between rooms and across the site.Indoor working conditions.Will work around moving equipment and machinery.May be required to work in a confined area.Some Clean Room and cool/hot storage conditionsMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
INT_2026
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IL - Round Lake - Drug DeliveryU.S. Base Salary Range:
$71,800.00 - $112,860.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
Yes Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionAbout the role:As a Maintenance Technician II, you will play a key role in ensuring reliable operation of all equipment used in the Galaxy filling process at Takeda’s Round Lake, IL manufacturing site. You will support and maintain equipment across the Mix, Fill, and Finishing complexes in the Drug Delivery facility, making sure manufacturing lines are properly maintained and ready to run during planned production periods.
This role is a night shift, 6:00pm – 6:30am in a 2-2-3 work schedule configuration.
How you will contribute:Perform preventive maintenance (PM) and monitor equipment during production to identify and resolve issues before they impact output.
Provide advanced troubleshooting and repairs for mechanical, electrical, pneumatic, and hydraulic systems.
Respond to equipment issues on an emergency basis, including working overtime, weekends, and during plant shutdowns as needed.
Become thoroughly familiar with corporate specifications, plant standard operating procedures (SOPs) for the Galaxy process, and local GMP requirements, ensuring they are consistently followed.
Adhere to all plant safety rules and actively promote safe work practices, including directing others in proper safety procedures.
Drive innovation and continuous improvement, working both independently and in collaboration with manufacturing, engineering, and quality teams to resolve issues and enhance performance.
Learn and understand corporate specifications and plant SOP's governing the operation of the Galaxy process and local GMP
Monitor assigned manufacturing lines and communicates with manufacturing to reduce down time
Provide a high level of troubleshooting to repair mechanical, electrical, pneumatic and hydraulic systems
Review current PMs, verifies parts are in stock and completes PMs
Build and rebuild machine assemblies
Communicate equipment issues and work status to supervisor, manufacturing, and management per the plant's Stop and Fix guidelines
Initiate work orders using the JD Edwards (JDE) CMMS system
Perform PM work and assign work related to the Galaxy process when work is required to maintain equipment reliability and efficiency; ensure timely completion of related documentation
Notes in JDE or other downtime tracking method any problems, breakdowns or alarms related to all equipment; initiate work orders, and provides additional documentation required to resolve issues; reviews equipment trends related to the issues and support efforts to eliminate reoccurring problems
Share knowledge and trains less experienced technicians in the Galaxy process and all related equipment including safety, 6S, PM's associated with the facility
Learn to handle robots in all normal production modes; troubleshoot problems related to robots, machine output and quality defects as they occur
Advances knowledge and capabilities through additional training
Solicit help from Lead technicians and engineering assistance when needed
What you bring to Takeda:High school diploma or GED equivalent required, plus 2+ years of experience or Associates degree or higher and 1+ years of related work experience
3+ years manufacturing systems experience.
Prior experience working in an FDA-regulated environment
Understand electrical, mechanical and pneumatic drawings
Experience with electrical, mechanical, hydraulic and pneumatic systems
Willingness to develop an understanding of programmable logic controllers (PLC)
Must not be allergic to Cephalosporin or their related products and minerals
Will travel up to 5% of the time
Important Considerations:At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Can work on multiple shifts, including weekends and holidays, to support a 24/7 manufacturing operation.
Will work non-traditional work hours or work overtime.
In general, your work will be a combination of sedentary work and walking around observing conditions of the facility.
Can carry up to 100lbs, lift up to 100lbs, push/pull up to 100lbs (with assistance of material handling equipment).
Will stand and walk for an extended period of time over an 8-12 hour shift between rooms and across the site.
May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks
Indoor working conditions
General office environment with air conditioning and heating
Will work around moving equipment and machinery
May work in confined spaces/areas.
More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IL - Round Lake - Drug DeliveryU.S. Hourly Wage Range:
$19.81 - $31.10
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
No Read LessBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job DescriptionBuild a stable career. Support your family. Help save lives.Are you looking for more than “just a job”? At Takeda, the work you do every day directly helps patients living with severe and chronic diseases. As a Manufacturing Technician II, you’ll assist in producing lifesaving and life-sustaining therapies that families around the world rely on—while building a stable, long-term career with excellent benefits and real growth opportunities.
If you have GMP manufacturing experience and are ready for a stable role with purpose, this might be the opportunity you’ve been searching for.
Why this role mattersEvery batch you help produce can mean saving a trauma patient, improving quality of life, and bringing renewed hope to patients and their loved ones. You are not just running equipment—you’re playing a critical role in making high-quality therapies available to people who depend on them every single day.
In this role, you will: Run and support production activities in accordance with cGMP, safety, and quality standards while operating key equipment such as DAP lines, forklifts, hoists, and moving products and materials through the production process.Lead the line, train junior technicians, and collaborate with other teams to achieve production and quality goals.Accurately complete batch documentation, keep your work area clean and ready for inspection, and promptly report safety, quality, or equipment issues to management.What we offer you:We understand that caring for patients begins with caring for our team. As a Manufacturing Technician II at Takeda, you can expect:
Stable, dependable employment: A full-time position with a reputable, global pharmaceutical leader.Competitive pay: Your GMP experience is valued and rewarded with industry-leading compensation.Outstanding benefits for you and your family: Comprehensive health coverage, paid time off, retirement contributions, tuition assistance, and other perks designed to support your life both inside and outside of work.Career growth and development: Clear opportunities to advance, learn new skills, and move into higher-level roles—your growth is integrated into our plan.Flexible shifts that support your life: Day shift is are available with our employee-friendly 2-2-3 rotating schedule, allowing you to plan around family and personal commitments. You must also be able to support a 24/7 manufacturing operation as needed, including overtime, weekends, holidays, and 12-hour shifts.A safe, supportive team environment: Work in a modern, clean facility with a team that looks out for one another and takes pride in doing things the right way.What you bring:We’re looking for people who take pride in their work and want a long-term career home.
GMP manufacturing experience is requiredHigh school diploma or GED required (associate’s degree or higher preferred)At least 2 years of related experience, or 1 year with an AA degreeAbility to speak, read, write, and follow work instructions in EnglishImportant Considerations:At Takeda, our patients rely on us to deliver safe, high-quality medicines, and we prioritize the health and safety of our employees. In this role, you may:
Able to carry, lift, and push/pull up to 30 lbs. (with material handling equipment when needed)Able to stand and walk for most of a 12-hour shift, including moving between rooms and across the siteComfortable bending, twisting, reaching overhead, squatting, and doing repetitive hand and arm motionsWork indoors around moving equipment and machinery, with some loud noise (hearing protection may be required)Work around chemicals such as alcohol, acids, buffers, and Celite (respiratory protection may be required)Work in controlled areas that require special safety gear and gowning, including protective clothing to cover the head, face, hands, feet, and bodyMay work in clean rooms and cool or hot storage areas, depending on departmentMust not be allergic to cephalosporin for specific product-touch rolesMust follow appearance rules in manufacturing areas (for example, no make-up, jewelry, nail polish, or artificial fingernails in designated areas)Able to work flexible or non-traditional hours to support 24/7 operations, including some overtime, weekends, holidays, and off-shift coverageMore About Us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1 #LI-MA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - IL - Round Lake - Drug DeliveryU.S. Hourly Wage Range:
$19.81 - $31.10
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
No Read Less