Senior Manager – Process Sciences (HYBRID)
Bio-Life Plasma, LLC
Lexington, MA
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Job Description
Position: Senior Manager - Process Sciences (HYBRID)
Location: Lexington, MA (Hybrid)
Reports to:
About the role:
Member of the global team of process science experts responsible for the manufacturing process for Takeda's large and diverse commercial biologics portfolio
Be a senior subject matter expert across the biologics portfolio
Provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products
How you will contribute:
Provide upstream and downstream technical expertise and leadership for multiple projects across the biologics portfolio, including lifecycle projects to ensure supply continuity, risk management, line extensions & discontinuation, process tech transfers, global expansion/contraction, regulatory activities, and capability & improvement.
Ensure technical continuity of manufacturing processes across sites and time
Provide technical expertise for projects and investigations which are complex or span multiple products
Lead process improvement projects that span sites or products
Ensure understanding of CMC content for multi-site products
Provide technical expertise required to maintain control strategy documents
What you bring to Takeda:
BS in engineering or life sciences disciplines with 12+ years experience, an MS with 10 years experience, or Ph.D .with 6 years experience in pharmaceutical development and manufacturing
Experience operating globally in a matrixed organization
Late-phase clinical, process development, or commercial manufacturing in mammalian cell culture experience is preferred.
Skills
Must have strong technical knowledge and experience in upstream or downstream process development
Interpersonal skills, and ability to analyze and solve complex problems through creative thought and experience.
Behaviors
Focus on a few priorities and provide superior results
Improve capabilities for now and the future
Provide leadership on teams
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. You may:
Work in a controlled environment requiring special gowning and wearing 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.
Workaround chemicals such as alcohol, acids, buffers, and Celite 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 empowers you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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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.
