Job DescriptionJob DescriptionSalary:
PurposeThe Associate Project Engineer will support the medical device team with the management and development of new and existing products. This will include product development, assembly, testing, and marketing as well as equipment management associated with products.
ResponsibilitiesSupport the development of new products in collaboration with the project team, Quality Assurance and Operations departmentsDevelop scalable and repeatable manufacturing processes for new products in collaboration with the Quality Assurance (QA) and Operations departmentsAuthor and revise standard operating procedures (SOP) according to FDA, and other regulations if applicablePerform CAD design, prototyping, and assembly as part of the development of new products and processesSupport the development and implementation of sales material for products and collaborate with QA/RA to ensure all claims are appropriate for market and regulatory positionDesign and execute scientific experiments for product development projects. Complete data collection, evaluation, and interpretation of results to generate statistically significant data to support project decisions and/or product launch. Experimentation may extend to in-vitro or in-vivo assays conducted in-house or externally sourcedCommunicate and negotiate with new or existing vendors to source and implement testing, equipment, supplies, materials, or other resources to support research project activitiesAssist the Operations department in the maintenance, assembly, installation, or implementation of new equipment or process specific toolingDesign, order, evaluate, and onboard new proprietary equipment and tools in support of manufacturing. Assist in the maintenance/calibration of new equipmentAssist in the development, drafting, and execution of verification and validation protocols in accordance with regulatory requirements and industry best practicesAssist with training and technology transfer for new projects and productsAssist in the development and maintenance of the project schedule for assigned projectsEnsure quality and quality control within their assigned projectsMaintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating proceduresMaintain effective communication with the project team on progress and challenges related to project tasksReport to work in-person and start job duties on time for established shiftComplete required hours on assigned works shift to complete assigned responsibilities and dutiesStart job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointmentsWork overtime during weekdays and on the weekend as needed to support business/operational needsPerform other related duties as assignedSkillsAbility to create and edit designs using CADWorking knowledge with design for manufacturing (DFM)Organized and self-motivatedExcellent attention to detailStrong analytical and creative thinking skillsEffective communication and technical writing skillsAbility to present complex ideasAbility to work in a fast-paced environmentAbility to work independently and in a team environmentCompetent in project managementProficient in Microsoft OfficeAbility to secure and maintain a favorable background investigation and clearance.
Qualifications/RequirementsBachelors degree in an Engineering, or biological science or related field requiredExperience with Mechanical DesignExperience with CAD SoftwareExperience or Knowledge in Project ManagementEntry Level Position
Job DescriptionJob DescriptionSalary:
PurposeThe Order Management Specialist is responsible for facilitating the entire order processing cycle, ensuring efficient and timely shipment of orders, delivering exceptional customer service, and partneringwith the shipping team to ensure accurate and prompt order fulfillment.ResponsibilitiesProvide exceptional customer service by promptly handling all inquiries related to customer orders via phone and email.Manage daily shipping reports and conduct end-of-day audits to verify accurate submission of customer orders.Respond to customer inquiries, including rush orders and order revisions, ensuring same-day resolution via preferred communication channels.Collaborate with the sales team to resolve order and shipping issues, providing timely solutions to customers.Maintain professional relationships with customers, partners, and vendors.Provide order status and tracking updates to leadership and customers as requested.Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.Maintain acceptable attendance and punctuality for scheduled work hours and meetings.Ensure completion of assigned tasks and responsibilities within defined timeframes.Maintain flexibility to work outside of normal business hours during weekdays or weekends, as necessary, to meet operational needs and ensure business continuity.Perform other duties as assigned.SkillsStrong interpersonal skills with the ability to handle high-pressure customer situations with professionalism.Proficient in Microsoft Office Suite or similar software, with the ability to quickly learn new systems.Strong attention to detail and ability to follow order management guidelines.Capability to work independently and collaboratively in a fast-paced environment.Familiarity with office equipment and the ability to adapt to dynamic changes.Excellent written and verbal communication.Highest level of ethics and integrity.Ability to lead and motivate the right behaviors.
Qualifications/RequirementsHigh school diploma or equivalent required.At least of 1-3 years of experience in customer service, order management, or related fieldClearance of favorable background investigation required.
Job DescriptionJob DescriptionSalary:
PurposeThe Manufacturing Engineering Technician will be an important member of the operations support team that ensures operational goals are met as measured by Safety, Quality, Delivery, and Cost. They will be involved with identification and implementation of manufacturing process improvements, collaborate with the R&D team on new products and processes, and provide preventive and corrective maintenance of equipment.
ResponsibilitiesContinually evaluate production machinery to identify opportunities that maximize machine efficiencies and continuous improvementTroubleshoot, maintain, and repair plant and facility machineryMaintain the equipment management software system to ensure compliance and effective group communicationRead and understand production machinery manuals to build knowledge and simplify troubleshooting and maintenanceIdentify potential safety issues throughout the facility and recommend appropriate resolutionsAssist with managing inventory of spare parts and supplies needed for plant and facility equipment to minimize downtimeInstallation & Design support of new production equipment and processesKey member of the safety team and responsible for design/status of equipment as it pertains to safetySupport an optimized production environment by applying principles of Lean ManufacturingCoordinate with external suppliers and maintenance companies to ensure timely and accurate completion of work including safetyAt time, will procure sparts parts to ensure equipment uptime is achieved and proper inventory is maintainedFrequently lifting between 10-25 pounds and occasionally lifting 50 pounds. Exposure to lifting more than 50 pounds is rareFrequently be subject to sustained bending, using hands to finger or handle or touch, use foot/feet to operate machine with constant exposure to dynamic standing/sittingOccasionally exposed to static standing/sitting, pushing/pulling (less than 50 lbs of force), floor to knuckle lift/lower (less than 50 lbs), knuckle to shoulder lift/lower (less than 50 lbs), shoulder to overhead lift/lower (less than 50 lbs), climb/balance, stoop, kneel, crouch or crawl, reach above shoulders and repetitive bending or squattingThe following vision requirements apply: close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focusConstantly exposed to working near moving mechanical parts with frequent exposure to risk of electrical shockOccasionally exposed to wet humid conditions, working in high precarious places, fumes or airborne particles, extreme cold or heat, outdoor weather conditions or travel on company business. The employee will rarely (if ever) be subject to toxic or caustic chemicals. The noise level is considered loud if near operating production equipmentRequired to wear appropriate Personal Protective Equipment such as safety glasses in the designated areas, hairnet/beard net, gloves when handling hot objects or solvents, jumpsuit, earplugs (when needed) on production floorFrequently use hand/power tools and machine equipment, with regular use of maintenance toolsFrequent use of a PC with Microsoft Office products. Occasional use of manlift/elevator, forklift and pallet/hydraulic jacks
Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/cGTP, other relevant regulations/standards, and internal organizational policies and standard operating proceduresMaintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframesFlexibility to work outside of norma business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessaryPerform other duties as assignedSkillsAbility to work independently and in a team environmentExcellent attention to detail and organizationExcellent written and verbal communicationHighest level of ethics and integrityAbility to lead and motivate the right behaviorsAbility to multi-task and work in a fast-paced environmentEffective project managementProficiency in Microsoft OfficeRequires basic knowledge of computers and operating systemsRequires strong mechanical aptitude and problem-solving skills to assess and improve equipment operationQualifications/RequirementsHigh school diploma or equivalent required from an accredited institutionAssociate's degree and/or 5+ years of relevant work experiencePrior experience with Computerized Maintenance Management Software system is highly preferred4-year degree may be substituted to meet up to years of experience requirementsClearance of favorable background investigation required
Job DescriptionJob DescriptionSalary:
PurposeThe Director of Project Management is responsible for leading the strategic direction and execution of all construction, capital improvement, and cross-functional project initiatives across the organization. This role oversees the planning, delivery, and governance of projects while ensuring alignment with corporate objectives. The Director will manage the Project Management Office (PMO), build and develop a high-performing project team, and serve as a strategic partner to executive leadership, driving operational excellence, scalability, and regulatory compliance in a fast-paced environment.ResponsibilitiesDevelop and execute the strategic vision for the PMO, aligning practices with long-term business goalsOversee construction, infrastructure, and operational projects, including new builds, facility expansions, and renovationsEstablish and maintain standardized project governance frameworks, policies, and proceduresOptimize project delivery through efficient resource planning, risk mitigation, and cost controlLead performance management for PMO staff, including hiring, development, annual goal setting, reviews, and improvement plansMonitor performance metrics and KPIs to ensure timely delivery, quality outcomes, and continuous improvementCollaborate cross-functionally with operations, engineering, facilities, finance, and executive leadership to prioritize and execute projectsServe as primary liaison for external vendors, contractors, and consultants, ensuring contract alignment and service qualityEnsure compliance with applicable safety regulations, building codes, and permitting requirements (e.g., OSHA, ADA, IBC)Guide change management efforts to support adoption of new tools, systems, or project methodologiesLead executive-level project reporting and communication across stakeholdersMaintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.Review and approve reimbursement requests for operational staff.Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes.Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.Perform other duties as assigned.SkillsAbility to work independently and in a team environment.Excellent attention to detail and organization.Excellent written and verbal communication.Highest level of ethics and integrity.Ability to lead and motivate the right behaviors.Ability to multi-task and work in a fast-paced environment.Strong technical writing.Effective project management.Proficiency in Microsoft Office.
Qualifications/RequirementsBachelors degree in Construction Management, Project Management, Engineering, Business Administration, or a related field requiredMasters degree preferredPMP, CCM, or equivalent project management certification requiredMinimum 810 years of progressive project management experience, including at least 5 years in leadership roleProven track record managing large-scale capital or construction projects, preferably in manufacturing, biotech, or regulated industriesExperience with organizational transformation and change management is a plusClearance of favorable background investigation required.
Job DescriptionJob DescriptionSalary:
Purpose
The Clinical Research Associate (CRA) is responsible for overseeing the operational aspects of clinical trial conduct at investigational sites to ensure data integrity, regulatory compliance, and adherence to Good Clinical Practice (GCP) guidelines. This role supports multiple clinical trials across various therapeutic indications and is instrumental in monitoring site performance, resolving issues, and facilitating communication between sponsor and site personnel.
ResponsibilitiesEvaluate clinical trial resourcing requirements for qualification (SQVs), training (SIVs), monitoring (IMVs) and support of sites during the conduct of the trialsWork with multiple trial sites and multiple studies of varying indications simultaneouslyDevelop and maintain a monitoring plan for assigned clinical trial(s)Liaise with external clinic and/or hospital investigators and associated staff conducting the trial as required to ensure the study and monitoring activities are meeting expectations from start of study to endOversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study
Oversee site activation process for each studyDevelop and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate cause and mitigate risk to studyPeriodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoringTrack patient enrollment and recommend solutions to trial site staff to increase appropriate enrollment of qualified subjectsProvide support for the processing of data queries, deviations, adverse events, etc.Write monitoring visit reportsDevelop and execute a plan to close trial sites on completion of the trial and perform associated closeout activitiesEnsure adherence to ICH-GCP, Standard Operating Procedures (SOPs), IRB regulation, and study protocolsEnsure adherence for regulatory compliance of investigational sites with SOPs, FDA regulations, and ICH guidelinesCoordinate with team data management activitiesGenerate protocol and Informed Consent drafts for management reviewCreate Literature Reviews for new study indicationsAssist with CRF developmentAssist with investigator meetingsCreate study status data tables and slide decks for upper management reviewCreate and maintain study site investigator binders from study start to endMaintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating proceduresStart job responsibilities punctually and ensure consistent presence throughout the entire shift to complete responsibilities properly and attend all scheduled meetings and appointmentsFlexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessaryPerform other duties as assignedSkillsIn-depth understanding of ICH-GCP, FDA regulations, and clinical research methodologyStrong organizational and problem-solving abilities with an eye for detailProficiency with Microsoft Office (Word, Excel, PowerPoint)Effective verbal and written communication skillsAbility to work both independently and collaboratively in a fast-paced environmentCapacity to manage travel and multiple site relationships simultaneouslyQualifications/RequirementsBachelor's degree (BA/BS) at minimum. Clinical research or life science degree preferred, can have relevant experience as a Physician Assistant, Nurse, EMT, and suchCertified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred but not required3+ years of relevant experience, preferred with at least two years of experience in industry or has worked with Sponsor companies as a clinic coordinatorPrior study supervision experienceDemonstrated working knowledge of GCP-ICH guidelines, and FDA regulationsDemonstrated ability to work independently and in a team environmentProficiency with MS Office (Word, Excel, PowerPoint)Excellent oral and written communication skills and strong organizational abilitiesClearance of favorable background investigation required
Job DescriptionJob DescriptionSalary:
PurposeThe PMO Manager provides visionary leadership to the organization's operations, ensuring appropriate project management and business analytic support to advance Tiger BioSciences strategic goals in general. This role will directly support the Tiger Franklin Operations business unit priorities in alignment with the aforementioned. This role involves leading assigned PMO staff, supporting business unit leader strategic priorities, driving digital transformation, optimizing operational performance, and implementing cutting-edge solutions in a dynamic medical manufacturing environment.ResponsibilitiesManage direct reports as assigned by the PMO DirectorMentor and develop PMO team members and department leadership, fostering a culture of accountability, innovation, and continuous improvement through feedback and guidanceConduct excellent stakeholder management through consistent and thorough communication and documentationExercise excellent emotional intelligence when working collaborativelyProvide constructive feedback and guidance to develop leadership in direct reports and department managementEstablish and monitor objective annual goals for direct reportsConduct performance reviews and establish performance improvement plans as neededRecruit, interview, and select personnel for hireEvaluate, recommend, and implement emerging technologies and solutions to meet business needsManage relationships with vendors, contractors, and external partners to ensure cost-effective technology procurement and supportOversee all projects supporting TWC as requested by TWC Executive Leadership, ensuring timely delivery and alignment with budget and compliance standardsExecute projects assigned by the PMO Director, or projects that otherwise require the attention and direction of the PMO ManagerOversee the implementation, upgrade and maintenance of enterprise systems, including but not limited to ERP, O365, and CRMEnsure IT governance processes comply with FDA regulations, ISO standards, and other applicable guidelinesLead project teams in managing applications architecture to ensure consistency and integrationMaintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and proceduresPartner with cross-functional teams to identify and implement technology solutions that support departmental objectivesTravel domestically up to 10% to attend offsite meetings, conferences, and support business initiativesMaintain flexibility to support business needs outside regular hours with advance notice, ensuring consistent attendance and punctualityPerform other duties as assignedSkillsFamiliarity with compliance frameworks such as GxP, FDA 21 CFR Part 11, or other regulatory standards relevant to highly regulated industriesFamiliarity working with data modeling and communicating concepts to leadersStrong project management and strategic planning skillsExcellent communication and stakeholder engagement capabilitiesQualifications/RequirementsBachelors degree in Business, Project Management, Leadership, or related field, from an accredited college or university requiredAt least 8-10 years of progressively responsible project management experienceCertified in Project Management PMP, CSM, CSPO, PMI-ACP or equivalent certificationExtensive knowledge of regulatory compliance within medical manufacturing or a similar highly regulated environment preferredSuccessful track record in leading cross-functional teams and driving organizational change requiredClearance of favorable background investigation required
Job DescriptionJob DescriptionSalary:
PurposeRegenTX is seeking an experienced and proactive Director of Facilities & Fleet to lead the strategic and day-to-day management of our facilities and company vehicle fleet across multiple locations in San Antonio, Texas. This role is responsible for ensuring the operational integrity, safety, compliance, and readiness of all RegenTX facilitiesincluding three manufacturing sites, two office sites, and future office locations currently in developmentthrough direct leadership of internal staff and coordination with critical external vendors. This role will also oversee maintenance and repairs of the companys vehicle fleet via third-party service providers.The Director will also serve as a key partner to Equipment Operations leadership to ensure facility infrastructure supports equipment performance and cleanroom operations. Additionally, this role will be actively involved in capital projectsincluding renovations, site expansions, and new facility developmentand will collaborate closely with the Enterprise Project Management Office (PMO) to ensure these projects are executed on time, within scope, and aligned with business objectives.ResponsibilitiesLead and develop the internal facilities team responsible for maintenance, upkeep, and safe operation of all RegenTX facilities.Manage preventive and corrective maintenance programs for all building systems, including HVAC, electrical, plumbing, fire protection, and building automation systems.Coordinate and support all infrastructure needs related to equipment installations, cleanroom environments, and production support utilities in close collaboration with Equipment Operations, Quality Assurance and Manufacturing.Maintain documentation of inspections, repairs, vendor service reports, and facility audits.Support strategic planning and execution for future office sites and site expansion projects.Participate in the planning, budgeting, and execution of facility-related capital projects, including renovations, expansions, and new construction.Provide input on facility design, utility requirements, infrastructure layout, and operational functionality to ensure long-term sustainability.Work closely with the Enterprise Project Management Office (PMO) to align capital projects with timelines, compliance requirements, and operational needs.Oversee or support on-site construction activities, vendor coordination, punch list resolution, and final turnover to internal stakeholders.Identify, negotiate, and manage third-party vendor contracts for maintenance, repairs, janitorial, landscaping, life safety systems, and specialized facility services.Monitor contractor performance to ensure high-quality work is completed on time and within budget.Maintain clear and detailed records of vendor work, contracts, and service level agreements.Oversee the maintenance and repair of the RegenTX vehicle fleet through third-party providers.Ensure vehicle safety, roadworthiness, and regulatory compliance are maintained at all times.Maintain accurate logs of fleet usage, service history, and coordinate timely preventative maintenance.Recommend vehicle replacements or acquisitions based on usage and operational needs.Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.Provide constructive feedback and guidance to develop leadership in direct reports and department management.Establish and monitor objective annual goals for direct reports.Conduct performance reviews and establish performance improvement plans as needed.Recruit, interview, and select personnel for hire.Travel domestically up to 10% to attend offsite meetings, conferences, and support business initiatives.Travel as needed between San Antonio facilities to support business needs as needed (~30%).Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.Perform other duties as assigned.SkillsStrong leadership skills with the ability to develop and mentor cross-functional teams.Solid understanding of facilities infrastructure systems, building codes, and regulatory requirements.Demonstrated success in managing capital improvement projects and collaborating with internal PMO teams.Proficiency in managing maintenance schedules and vendor service contracts.Excellent communication and organizational skills, with the ability to manage multiple priorities in a fast-paced environment.
Proficiency in facility management systems or CMMS platforms is a plus.Valid drivers license and ability to travel between company sites as needed.Ability to work independently and in a team environment.Excellent attention to detail and organization.Excellent written and verbal communication.Highest level of ethics and integrity. Ability to lead and motivate the right behaviors.Ability to multi-task and work in a fast-paced environment.Effective project management.Proficiency in Microsoft Office.
Qualifications/RequirementsBachelors degree required with preferred in: Facilities Management, Engineering, Construction Management, Business Administration/Management.Minimum of 7 years of facilities management experience, with at least 3 years in a leadership capacity.Direct experience in a regulated manufacturing environment required (biotech, medical device, laboratory, tissue bank, blood bank, food).Proven experience managing multiple sites and leading facility-related capital projects (renovations and/or new) from design through completion.Experience managing small vehicle fleets preferred.Clearance of favorable background investigation required.
Job DescriptionJob DescriptionSalary:
PurposeThe Senior Project Manager leads projects and project related work contributing value to the Project Management Office and our stakeholders. This role is responsible for being project leaders within the company capable of guiding cross-functional teams to successful outcomes. This role draws upon demonstrated project skills to manage the following project types: 1) Standard: routine and repeatable projects that are familiar in practice and form, 2) Non-standard: project situations where scope is unclear, customer is unsure of their actual need, or typical solutions applied in prior situations are not feasible and thinking outside the box is required to move forward, and 3) Complex: project scenarios where scope is unclear, expectations are not aligned across the stakeholder group, emotional intelligence is required to navigate challenging political scenarios, and/or where competing priorities are shifting during the project life-cycle requiring resetting of expectations and appropriate escalation to executive leadership.Responsibilities Mentor and Coach less experienced staff within the PMO Assist the PMO Director in duties as assigned, both project and operational Act as project leader on projects and programs as assigned Organize work in accordance with team standards Lead and facilitate project and operational meetings as assigned Approach all decision-making with the customers needs as priority Conduct excellent stakeholder management through consistent and thorough communication and documentation Exercise excellent emotional intelligence when working collaboratively Drive cross-functional collaboration and decision-making through entire project life-cycles; accountable for overall project performance Collaborate with kay stakeholders to understand project requirements, expectations, priorities, and ensure transparent communication throughout the project life cycle Identify potential risks and issues related to project delivery and develop mitigation strategies to minimize impact Be accountable for and ensure coverage of project activities that occur outside of typical business hours on premise Recommend process improvements for the PMO and assist the Director of PMO in implementing changes across the team Demonstrable ability to operate in multiple locations supporting projects Lead innovative solutioning for novel project situations preventing inertia from slowing expected progress Lead and support teams from multiple locations across San Antonio as needed Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures Travel domestically up to 20% to attend offsite meetings, conferences, and support business initiatives Start job duties on time, stay on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments Work overtime during weekdays and on the weekend as needed to support business/operational needs Perform other related duties as assignedSkills Excellent project leadership and collaboration skills Strong problem solving and decision-making abilities Exceptional meeting facilitation and communication skills required Ability to manage multiple projects and priorities in a fast-paced environment Exceptional project management and organizational skills Ability to secure and maintain a favorable background investigation and clearance Intermediate to Advanced skill level with the following applications: Smartsheet, Primavera P6, Jira, Monday, Asana MS Office Suite (Outlook, OneNote, Teams, Project)
Qualifications/Requirements Bachelors degree in business administration, project management, or related field from an accredited college or university required Masters degree preferred PMP certification or an equivalent project management certification is required Lean Six Sigma (Green, Yellow or Black) is highly preferred Minimum of 5 years of project management experience Experience in medical device manufacturing is highly preferred; experience in manufacturing in other industries is also preferred Strong understanding on project management methodologies, tools and techniques Excellent project leadership, communication, and interpersonal skills, with the ability to effectively influence and collaborate with stakeholders at all levels of the organization Experience driving process improvement initiatives and implementing best practices is a plus Clearance of favorable background investigation required
Job DescriptionJob DescriptionSalary:
PurposeThe Research Manager is responsible for the management of the research laboratory, planning, managing, and supporting of the research projects within the Product Research team. The Research Manager will coordinate activities, provide technical support and expertise, and ensure effective operation of the Research Laboratory.ResponsibilitiesProvide technical expertise and guidance to research staff by supporting experimental design, data interpretation, troubleshooting, and the development and execution of project deliverablesCollaborate with cross-functional teams, including product development, to ensure research findings are integrated into product pipelinesEnsure research activities are clearly defined to mitigate scope creepReview and approve research plans to ensure projects deliver on business, marketing, regulatory and product development requirementsDevelop and track performance metrics to measure research progress, productivity, and impactAnalyze research progress, monitor risk, and identify opportunities for improvement to ensure timely completion of deliverablesManage project timelines, budgets, and resources to optimize efficiencyReview and approve research reports, white papers, or manuscripts written in-house or by contract laboratories and consultantsManage research agreements and collaborations with external research sitesMaintain laboratory safety standards and regulatory complianceReview and approve new guidelines, procedures, and protocols for research activities and laboratory operationsMaintain laboratory operations, including equipment calibration, inventory management, and vendor relationships, to support ongoing research needsAssist with the identification development of research test methods and approaches that support organizational and product development goalsSupport and mentor research staff to foster collaboration, innovation, and a positive work environmentConduct and schedule training of research staff in laboratory techniques, equipment use, safety practices, or other applicable activities in support of research projects Maintain working knowledge of advances in science, regulatory requirements, and industry trendsMaintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, relevant regulations/standards, and internal organizational policies and standard operating proceduresManage direct reportsProvide constructive feedback and guidance to develop leadership in direct reports and department managementEstablish and monitor objective annual goals for direct reportsConduct performance reviews and establish performance improvement plans as neededRecruit, interview, and select personnel for hireTravel domestically up to15% to attend offsite meetings, conferences, and support business initiativesMaintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of tasks and responsibilities within defined timeframesFlexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessaryPerform other duties as assignedSkillsHighest level of ethics and integrity Excellent verbal and written communication skills for effective collaboration and complex scientific discussions
Strong organizational, multitasking, and detail-oriented skills with the ability to meet tight deadlines
Strong understanding of the intersection between scientific research, product development, and business strategyCapable of working independently or part of a team
Effective project management skills, from planning through execution and completionAbility to lead and motivate the right behaviorsAbility to multi-task and work in a fast-paced environmentStrong technical writingAbility to multi-task and work in a fast-paced environmentProficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and statistical softwareQualifications/RequirementsDoctoral degree in a scientific discipline (e.g., biology, biomedical sciences, bioengineering) with 6 years of post-education research experienceAt least 1 year of experience in managing a research laboratory
At least 4 years of experience in team leadership, direct supervision, project management and technical writing with contributions to peer-reviewed manuscripts and grant submissions in academic, government or industry settings
Masters degree with a thesis and 8 years of post-education research experience in industry may be substituted to meet doctoral degree requirementClearance of favorable background investigation required
