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Takeda Pharmaceutical
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  • Sr. Utilities Technician - Waste Water  

    - SOCIAL CIRCLE
    By clicking the “Apply” button, I understand that my employment applic... Read More

    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 Description

    About the role: 

    The Utilities Technician is responsible for the operation, maintenance, and troubleshooting of plant equipment that supports utilities including but not limited to high-pressure steam boilers; chillers; heating/cooling air handling units; process wastewater treatment systems; water purification system (water softening and carbon bed filtration, reverse osmosis, continuous deionization equipment, sanitary pumps, multi-effect distillation equipment); tank mixers; air compressors and dryers; and chilled water distribution systems under minimum supervision of the utilities supervisor in rotation shift environment.

    Performs corrective maintenance and routine preventative maintenance on plant utilities equipment following Standard Operating Procedures (SOPs) as necessary. Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory.  This senior position is responsible for performing daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies.

    How will you contribute:Perform preventive, corrective and predictive maintenance of all associated equipment.Operate and maintain various equipment through routine inspection and review.All work must be completed in accordance with cGMPs, SOPs, job plans, and company policies.Read, understand, and follow related SOPs and job/work plans.Ensure that forms and work order documentation are completed with accurate information.Responds to calls and conduct repairs throughout the facility. May be assigned to escort a contractor performing work on the premises.Provide support for the start-up of new equipment to ensure it meets all mechanical design specifications.Develop a proficiency in three or more advanced maintenance technologies and understand how to apply technology to improve equipment reliability, e.g., alignment, balancing, thermography, oil analysis, ultrasound, or vibration monitoring.Must follow safety rules and ensure compliance with GA state and federal EPA regulations and laws.Collect and Analyze daily WWTP as per procedurePerform chemical / parameter adjustment in WWTP as need it to maintain the system in compliancePerform Disposal of Hazardous WasteRespond to urgent and emergency work orders for the utilities department as needed.Responsible for closing assigned work orders in the CMMS (JDE, Maximo, SAP).Attend required Instructor Lead Training and planned team meetingsDemonstrate continuous progress with respect to increasing job knowledge and proficiency in technical understanding/problem-solving.Order and Maintain chemical inventoryKeeps designated area 5S'd. (Safety, Sort, Shine, Standardize, Sustain)Ability to teach basic activities and work execution to other technicians.Maintain a positive, professional, and customer-oriented attitude. Communicate any concerns related to safe work practices, hostile work environment, sexual harassment or any other type of employee misconduct directly to their supervisor, or management.This position will receive general instruction on routine work with detailed instruction on new assignments. Often will be assigned to work with a less experienced, utilities or maintenance technician.Primarily interacts with Plant Engineering Department personnel. Moderate interaction with other departments.May perform other duties as assigned.Provide a limited level of troubleshooting, diagnostic, and repair of building systems, equipment, and equipment components. Manufacturing equipment vessels, mixers, valves, and pumps.Operate general laboratory equipment to assess the analytical status of the utilities process.

    What you bring to Takeda:Typically requires a high school diploma or GED plus 8+ years of related industrial related experience. Pharmaceutical, utilities, and/or WWTP experience preferred.Two-year certificate in a technical field such as HVAC, building trades or building utilities program, or equivalent military experience is preferred.5-6 years of experience in the maintenance trades is preferredAbility to read and understand technical manuals and wiring schematicsMust have good customer service skills and promote a teamwork environmentMust have GA Industrial Wastewater Operator license or higher (or ability to get it within 90 days of employment)Ability to effectively communicate ideas through verbal and written form.Ability to read and understand procedures, schematics, and job blueprints.Familiar with CMMS, SAP, JDE, and or MaximoMust be able to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.Excellent technical troubleshooting/problem solving skills are a must. Must be knowledgeable with respect to the operation and maintenance of various utility systems including DAF, Centrifuge, Aeration Basins, Blowers, Pumps and others.Familiarity with Microsoft Office Applications, SCADA, process control software, and other computer base applications

    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, or be asked to work supplemental hours, as necessary.May be exposed to sunlight and heat.May be exposed to dust, gases, and fumes.May be required to stand and walk frequently while evaluating utilities equipment.May be around moving equipment and machinery.May climb up and into large tanks for inspection.May work in a loud area that requires hearing protection and other protective equipment to be worn.May be required to work or be assigned to a different shift as needed.Must be able to work 12-hour shifts and rotate(2/2/3) with assigned shifts.Overtime may be required at times.Requires performing activities within the plant utilities equipment, mechanical work, and computer-based activities.May be required to lift up to 50 pounds when managing chemicals.No travel is expected with this position.

    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 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.

    #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 - GA - Social Circle - Hwy 278

    U.S. Hourly Wage Range:

    $27.55 - $43.26


    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 - GA - Social Circle - Hwy 278

    Worker TypeEmployee

    Worker Sub-TypeRegular

    Time TypeFull time

    Job Exempt

    No

    Read Less
  • Senior Maintenance Technician - Electrician  

    - SOCIAL CIRCLE
    By clicking the “Apply” button, I understand that my employment applic... Read More

    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 Description

    About the role:          

    The Utilities Technician - electrician is responsible for the operation, maintenance, and troubleshooting of plant equipment that supports utilities including but not limited to high-pressure steam boilers; chillers; heating/cooling air handling units; process wastewater treatment systems; water purification system (water softening and carbon bed filtration, reverse osmosis, continuous deionization equipment, sanitary pumps, multi-effect distillation equipment); tank mixers; air compressors and dryers; and chilled water distribution systems under minimum supervision of the utilities supervisor in rotation shift environment. Performs corrective maintenance and routine preventative maintenance on plant utilities equipment following Standard Operating Procedures (SOPs) as necessary. Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory.  This senior position is responsible for performing daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies.

    How you will contribute:Perform preventive, corrective and predictive maintenance of all associated equipment.Operate and maintain various equipment through routine inspection and review.All work must be completed in accordance with cGMPs, SOPs, job plans, and company policies.Read, understand, and follow related SOPs and job/work plans.Ensure that forms and work order documentation are completed with accurate information.Responds to calls and conduct repairs throughout the facility. May be assigned to escort a contractor performing work on the premises.Provide support for the start-up of new equipment to ensure it meets all electrical design specifications.Repair, replace and install sensors, actuators, transformers, controllers, circuit breakers, motors, heating units, electric eyes, conduit systems, switches, defective writing, etc.Troubleshoot, repair, and replace PLCs, Servo and Frequency Drives, and related electronic hardwareDisassembles, inspects, reassembles, troubleshoots, repairs, and replaces malfunctioning parts or equipment (motors, switches, sensors, input /output boards, controllers servos, gears, sprockets chains, knives, etc. using test equipmentMust follow safety rules and ensure compliance with GA state and federal EPA regulations and laws.Perform Disposal of Hazardous WasteRespond to urgent and emergency work orders for the utilities department as needed.Responsible for closing assigned work orders in the CMMS (JDE, Maximo, SAP).Attend required Instructor Lead Training and planned team meetingsDemonstrate continuous progress with respect to increasing job knowledge and proficiency in technical understanding/problem-solving.Keeps designated area 5S'd. (Safety, Sort, Shine, Standardize, Sustain)Ability to teach basic activities and work execution to other technicians.This position will receive general instruction on routine work with detailed instruction on new assignments. Often will be assigned to work with a less experienced, utilities or maintenance technician.Primarily interacts with Plant Engineering Department personnel. Moderate interaction with other departments.May perform other duties as assigned.

    What you bring to Takeda:Typically requires a high school diploma or GED plus 8+ years of related industrial related experience. Pharmaceutical, utilities, and/or WWTP experience preferred.Two-year certificate in a technical field such as ElectricianProficiency in electrical circuits, schematics, servo motors, and familiarity with 460/220 3 PH wiring. HVAC, building trades or building utilities program, or equivalent military experience is preferred.5-6 years of experience in the maintenance trades is preferredAbility to read and understand technical manuals and wiring schematicsMust have good customer service skills and promote a teamwork environmentAbility to effectively communicate ideas through verbal and written form.Intermediate computer skills.Ability to interact constructively with peers and other teams.Ability to seek outside resources as needed.Ability to read and understand procedures, schematics, and job blueprints.Provide a limited level of troubleshooting, diagnostic, and repair of building systems, equipment, and equipment components.Manufacturing equipment vessels, mixers, valves, and pumps.Operate general laboratory equipment to assess the analytical status of the utilities process.Familiar with CMMS, SAP, JDE, and or MaximoMust be able to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.Familiarity with Microsoft Office Applications, SCADA, process control software, and other computer base applications

    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, or be asked to work supplemental hours, as necessary.Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.May be exposed to sunlight and heat.May be exposed to dust, gases, and fumes.May be required to stand and walk frequently while evaluating utilities equipment.May be around moving equipment and machinery.May climb up and into large tanks for inspection.May work in a loud area that requires hearing protection and other protective equipment to be worn.May be required to work or be assigned to a different shift as needed.Must be able to work 12-hour shifts and rotate(2/2/3) with assigned shifts.Overtime may be required at times.Requires performing activities within the plant utilities equipment, mechanical work, and computer-based activities.May be required to lift up to 50 pounds when managing chemicals.No travel is expected with this position.

    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 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.

    #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 - GA - Social Circle - Hwy 278

    U.S. Hourly Wage Range:

    $27.55 - $43.26


    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 - GA - Social Circle - Hwy 278

    Worker TypeEmployee

    Worker Sub-TypeRegular

    Time TypeFull time

    Job Exempt

    No

    Read Less
  • By clicking the Apply button, I understand that my employment applicat... Read More
    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 Description About the role: At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Director, Global Regulatory Lead Oncology you will set global regulatory strategy and lead major submissions for high-impact oncology programs. How you will contribute: Oversee as well as execute all regulatory activities of one or multiple complex projects in development and/or supports regulatory activities for assigned projects. Serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility. May lead the global regulatory sub-team (GRT) for assigned projects. May serve as global and/or regional regulatory lead as a member of a GRT Primary FDA contact for projects of responsibility. Accountable for all US FDA submissions and approvals of project(s) of responsibility. Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA) For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Participate with influence in or leads departmental and cross-functional task-forces and initiatives. May partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Develop/author and execute global regulatory strategies for complex strategies. May oversee execution. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. May lead regulatory assessment as part of due diligence teams for licensing opportunities. Identify and propose solutions to management for any resource gaps for assigned project(s). May present to senior management as requested. Participate with influence in or leads departmental and cross-functional task-forces and initiatives. Minimum Requirements/Qualifications: Bachelor's Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred. A minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus. Experience in managing major regulatory filing(s); and experience as a significant contributor to regulatory and/or development strategies Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrate strong skills with increasing independence in the area of regulatory strategy. Strong ability to work well with others and within global teams; and acceptable at communicating with senior leadership. Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. 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 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. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 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, MA U.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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It 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 Less
  • By clicking the Apply button, I understand that my employment applicat... Read More
    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. At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters. Interacts directly with international Health Authorities on administrative procedural topics, as required. Evaluates change proposals for global regulatory impact. As a GRA CMC member, ensures regulatory compliance with HA regulations. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Supports and/ or leads assigned global regulatory submissions (e.g., Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. BS/BA Degree in a Scientific Discipline, Advanced Degree (M.10+ years of overall biopharmaceutical/device industry experience with 5+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered). Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal supervision. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. S. based employees may be eligible for short-term and/ or long-term incentives. 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. Read Less
  • By clicking the Apply button, I understand that my employment applicat... Read More
    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. The Utilities Technician - electrician is responsible for the operation, maintenance, and troubleshooting of plant equipment that supports utilities including but not limited to high-pressure steam boilers; heating/cooling air handling units; water purification system (water softening and carbon bed filtration, reverse osmosis, continuous deionization equipment, sanitary pumps, multi-effect distillation equipment); air compressors and dryers; and chilled water distribution systems under minimum supervision of the utilities supervisor in rotation shift environment. Performs corrective maintenance and routine preventative maintenance on plant utilities equipment following Standard Operating Procedures (SOPs) as necessary. Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory. This senior position is responsible for performing daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies. Perform preventive, corrective and predictive maintenance of all associated equipment. Operate and maintain various equipment through routine inspection and review. All work must be completed in accordance with cGMPs, SOPs, job plans, and company policies. Responds to calls and conduct repairs throughout the facility. May be assigned to escort a contractor performing work on the premises. Provide support for the start-up of new equipment to ensure it meets all electrical design specifications. Repair, replace and install sensors, actuators, transformers, controllers, circuit breakers, motors, heating units, electric eyes, conduit systems, switches, defective writing, etc. Troubleshoot, repair, and replace PLCs, Servo and Frequency Drives, and related electronic hardware Disassembles, inspects, reassembles, troubleshoots, repairs, and replaces malfunctioning parts or equipment (motors, switches, sensors, input /output boards, controllers servos, gears, sprockets chains, knives, etc. using test equipment Respond to urgent and emergency work orders for the utilities department as needed. Responsible for closing assigned work orders in the CMMS (JDE, Maximo, SAP). Attend required Instructor Lead Training and planned team meetings Often will be assigned to work with a less experienced, utilities or maintenance technician. Typically requires a high school diploma or GED plus 8+ years of related industrial related experience. Pharmaceutical, utilities, and/or WWTP experience preferred. Two-year certificate in a technical field such as Electrician Proficiency in electrical circuits, schematics, servo motors, and familiarity with 460/220 3 PH wiring. HVAC, building trades or building utilities program, or equivalent military experience is preferred. 5-6 years of experience in the maintenance trades is preferred Must have good customer service skills and promote a teamwork environment Intermediate computer skills. Provide a limited level of troubleshooting, diagnostic, and repair of building systems, equipment, and equipment components. Manufacturing equipment vessels, mixers, valves, and pumps. Operate general laboratory equipment to assess the analytical status of the utilities process. Familiar with CMMS, SAP, JDE, and or Maximo Must be able to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry. Familiarity with Microsoft Office Applications, SCADA, process control software, and other computer base applications 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. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. May be exposed to dust, gases, and fumes. May be required to stand and walk frequently while evaluating utilities equipment. May be around moving equipment and machinery. May climb up and into large tanks for inspection. May work in a loud area that requires hearing protection and other protective equipment to be worn. May be required to work or be assigned to a different shift as needed. Must be able to work 12-hour shifts and rotate(2/2/3) with assigned shifts. Overtime may be required at times. Requires performing activities within the plant utilities equipment, mechanical work, and computer-based activities. May be required to lift up to 50 pounds when managing chemicals. No travel is expected with this position. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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. Hourly Wage Range: $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. S. based employees may be eligible for short-term incentives. S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match]] Read Less
  • By clicking the Apply button, I understand that my employment applicat... Read More
    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. R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity: Research Senior Associate Takeda Development Center Americas, Inc. is seeking a Research Senior Associate with the following duties: design and execute in vitro antibody discovery campaigns using yeast and phage display techniques. Generate diverse repertoires from immunized animals to build immune libraries for discovery purposes. Design and build maturation libraries for display platforms (affinity/potency/ stability), leveraging datasets and software to improve lead candidates. Prepare samples for sequencing by NGS or Sanger methodologies, including data analysis. Perform mammalian cell culture, ELISA and flow cytometry experiments, including sorting by utilizing BD Canto, ARIA and HT systems. Develop and use molecular cloning strategies for antibody gene amplification, library construction, and for generating antibody diversities for display libraries. Complete molecular biology techniques including DNA and RNA extraction, PCR, RT-PCR, restriction enzyme digestions and site directed mutagenesis. perform calculations and basic analysis on experimental results and develop hypotheses. maintain responsibility for routine laboratory instrumentation and supplies; track, collect, organize and analyze data from matrix teams; required to track data from LIMS systems and maintain detailed electronic notebook. Up to 20% remote work allowed. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. S. based employees may be eligible for short-term and/or long-term incentives. 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. Master's degree in Biochemistry, Biotechnology, Molecular. Biology, Immunology Bioengineering, or related field, plus 1 year of related experience. build immune/single domain phage libraries using molecular biology techniques; independently handle and lead projects from discovery to clone selection for target discovery campaigns; design recombinant plasmids to generate overexpressing/knock-out cell-lines using molecular biology; laboratory experience in yeast and/or phage display, antibody discovery, molecular biology or related research role. Full time. $Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210. Full time Read Less
  • By clicking the Apply button, I understand that my employment applicat... Read More
    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 Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Medical Director, Clinical Science, Solid Tumor in our Cambridge 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. OBJECTIVES: The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences TGRD and TPC senior leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products. ACCOUNTABILITIES: Clinical Development team participation and leadership Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy. Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, and influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. A significant error in judgment may result in loss of approvability and commercial viability of a product. Synopsis / Protocol Development, Study Execution, Study Interpretation Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determine how individual study results impact the overall compound strategy. Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients. Trial Medical Monitoring Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues. Makes final decisions regarding study conduct related to scientific integrity. External Interactions Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives. Due Diligence, Business Development and Alliance Projects Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda's strategic goals while striving to maintain good working relationship between Takeda and partner. Leadership, Task Force Participation, Upper Management Accountability Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross-functional teams, as appropriate. Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Education/ Experience MD, combined MD/PhD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned). Training and Experience in Hematology/ Oncology and/or Medical Oncology especially in solid tumor malignancies is preferred Experience in conducting and/or leading clinical trials involving immune-based therapies and/or antibody-drug conjugates is preferred. Late phase clinical development and NDA/MAA/Submission experience is preferred. Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions. Management experience Skills Excellent communication and influencing skills, with the ability to engage, inspire, and influence stakeholders at all levels, including executive management and external partners.Ability to proactively predict issues and solve problems Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams Diplomacy and positive influencing abilities Knowledge Therapeutic area knowledge relevant to mechanism of action Regional/global Regulatory requirements GCP/ICH Emerging research in designated therapeutic area TRAVEL REQUIREMENTS: Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 15 - 25% travel. Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regar]] Read Less
  • By clicking the Apply button, I understand that my employment applicat... Read More
    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 Description About the role: At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. How you will contribute: With guidance from leadership: Management of Labeling Cross-Functional Teams Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance. With adequate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content. Precedent Search and Labeling Trends Conducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. Working within Labeling Team and GRA Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Represents global labeling in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience. Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required). Knowledge of US and/or EU regulatory requirements and guidelines. Knowledge of other relevant regional regulatory nuances and requirements. Knowledge of scientific principles and regulatory/quality systems relevant to drug development. Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance. Ability to develop target labeling profile (TLP) with minimal supervision and guidance. Understanding of the broad concepts within global labeling and implications across the organization and globally. Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. 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 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. This position is currently classified as remote following Takeda's Hybrid and Remote Work policy. 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 - Virtual U.S. Base Salary Range: $154,400.00 - $242,550.00 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 medic Read Less
  • By clicking the Apply button, I understand that my employment applicat... Read More
    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 Description Objectives: Takeda is a global, values-based, R D-driven, top 15 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) 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 Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistics function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. About the role: A Manager in Statistics is expected to: Own assigned tasks to enable delivery, identifies the need for, and actively seeks input from others on delivery challenges Engage cross functionally and with vendors to progress delivery by influencing Lead activities within parts of project delivery including studies or submissions, or exploratory work related to clinical, preclinical, or translational drug R D Establish internal and external presence on delivery risks Introduce delivery mitigations CORE ELEMENTS RELATED TO THIS ROLE Knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics. Knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents. Knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions. Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products). Excellent oral and written communications skills The Manager in Statistics needs to: Have ability to identify appropriate methods for standard and common scenarios Have experience with multidisciplinary environment in applying methods Be able to introduces new method ideas and improves on existing analysis and method Own assigned tasks, identifies the need for and actively seeks input from others Engage cross functionally to progress tasks by influencing Lead activities and parts of projects including studies or submissions, or exploratory work related to clinical, preclinical, or translational drug R D EDUCATION: PhD in statistical or quantitative field MS with ~3+ years experience in statistical or quantitative field 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, MA U.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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It 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 Less
  • By clicking the Apply button, I understand that my employment applicat... Read More
    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. At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody-drug conjugates (ADCs), complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global regulatory team. In this influential role, you will lead a top-priority program, building cross-functional teams capable of translating complex challenges and ideas into actionable strategies. You will set global regulatory direction, provide expert guidance, and lead late-stage projects to ensure innovative and robust strategies are in place from development through registration and launch readiness for high-impact oncology programs. Lead global regulatory strategy for assigned programs across development stages. Provide strategic, operational and tactical regulatory insight on one or multiple complex global oncology projects in clinical development with focus on innovative ways of addressing barriers to development strategies as well as accelerating access of our products to patients Will be responsible for complex and potentially multiple projects within the Oncology TAU. Interfaces with the Global Project Team (GPT) to lead and support cross-functional company objectives. Serve as global regulatory lead (GRL)/ Franchise global regulatory lead (GRL) on cross-functional teams for priority programs, providing strategic input and regulatory expertise. Leads the Global Regulatory Teams (GRT) accountable for the development of innovative global strategies in line with applicable regulations to achieve business objectives for development of Oncology products. When necessary, seeks expert advice and technical support from functional stakeholders and senior management. Acts independently under the direction of a Global Regulatory Portfolio Lead and/or TA Head. May participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRT members. Ensures alignment of global regulatory strategies with Leadership Team. Presents meaningful regulatory assessments and regulatory recommendations to management. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercise sound judgement and communicating in a professional and timely manner. Accountable for US FDA submissions and approvals of project(s) of responsibility. May serve as the primary FDA point of contact for projects of responsibility. Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA) For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Develop/author and execute global regulatory strategies for complex strategies. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. May lead regulatory assessment as part of due diligence teams for licensing opportunities. Identify and propose solutions to management for any resource gaps for assigned project(s). BSc/BA Degree, scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Experience in reviewing, authoring, or managing components of regulatory submissions including for Late-Stage assets. Solid working knowledge of drug development process and regulatory requirements. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. S. based employees may be eligible for short-term and/ or long-term incentives. 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. Read Less

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