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Job Description

About the role:

Join Takeda as the Head of Quality Control Testing at our MA Biologics Operations manufacturing site where you will lead the quality control laboratories including HPLC, Biochemistry, Cell Biology, Raw Materials, Microbiology, and Cell Banking disciplines at the Lexington, MA site. The labs are accountable for the on-time delivery of data to support in-process, release and stability activities. You will also provide direct leadership to a large motivated team. As part of the Site Quality Leadership Team, you will report to the MA Bio Ops Site Quality Head and work with teams across Quality, Manufacturing, Engineering and Supply Chain.

How you will contribute:

• Bring accountability to deliver to targets for commercial and clinical testing of defined site-based and external programs, collaborate on continuous improvement (Cl) activities, engage with peers across the Lexington site to influence daily operations, and progress lean labs programs.

• Maintain labs in an inspection-ready, GMP-compliant state.

• Introduce new technology to improve sustainability and compliance is expected.

• Support New Product Introduction (NPI) according to the MA Bio Ops strategy.

• Oversee activities for investigations and root cause analysis to support quality systems; Cl and other project activities; method introduction and support; and other operations support such as visual board management, technical writing activities, non-routine protocol oversight.

• Lead individuals, including goal setting, performance feedback, skills development, and mentoring.

Minimum Requirements/Qualifications:

• Minimum of a bachelor's degree in a scientific discipline and 15 or more years related experience in a Biotech environment, especially in a Quality Control laboratory

• GMP experience is necessary

• Demonstrated ability to solve problems, drive improvement, and develop plans and advance to completion on time and in full

• Prior people management experience

• Diverse technical understanding and ability to apply skills/knowledge to new technology

• Knowledge of cGMPs/GDPs

• QC laboratory experience

• Knowledge of quality systems

• Experience in continuous improvement / operational excellence

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Paid time off for vacation, sick leave, and volunteering

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional development opportunities

• Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. 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.

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" in accordance with Takeda's Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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.

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