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Job Description

Job Title: Lab Services Manager

Location: Lexington, MA

About the Role:

• Strong understanding of how a QC Microbiology Lab functions and its role within the organization
• Represent QC for new product introduction projects
• Ownership of quality documents and quality system tasks and records will be required, including deviations, CAPAs, change controls, technical protocols, gap assessments, and periodic reviews
• Works alongside QC, Manufacturing, Quality Assurance, and other applicable departments to drive work to completion
• Attend all project team meetings
• Manage a team of contractors
• Own relevant quality documents and quality systems related to QC microbiology
• Provide inspection and regulatory support on behalf of QC as needed.

How you will contribute:

60% - NPI

30% - Quality Documentation and quality systems (i.e., technical protocols, periodic reviews, gap assessments, CAPAs, change controls, and deviations)

10% - Inspection and Regulatory Support

What you bring to Takeda:

Typically requires a minimum of 8 years of related experience. Bachelor's degree in technical or scientific discipline preferred. Experience with writing quality documents in pharmaceutical biologics. Experience with new product introduction projects. Familiar with Quality Systems such as CAPA, change control and deviations.

• Ability to work with minimal supervision and prioritize and direct own work.
• Strong interpersonal and communication skills.
• Ability to work in cross functional teams and excuting work to meet established timelines.
• Strong technical writing skills.
• 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
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional training and development opportunities
• Tuition reimbursement

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.

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 posting excludes Colorado applicants.

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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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