Takeda Pharmaceuticals Senior QC Stability Specialist in Lexington, Massachusetts
About the Role:
You will oversee project management of stability studies for Drug Products, Drug Substances, and Intermediates and associated Data Evaluations and Documentation. You will assign and continuously monitor product shelf life, and author technical documents for regulatory submissions. This is a hybrid role that will report to the Head of Analytical Services, OESSM.
How you will contribute:
Management of stability studies for assigned products, and generation of stability protocols and reports (e.g. final reports, PQRs, annual reports, SOPs)
Author and review of stability sections for regulatory submissions
Write and review of responses for health authority requests and communication with regional authorities
Statistical analysis and evaluation of stability data (e.g. Shelf Life or Internal Alert Limit determination)
Subject matter expert for stability during audits and inspections
Stability OOS/OOT investigation ownership
Evaluate transport temperature excursions
Perform change request assessments with regard to stability
Generation and review of SOPs and forms for processes associated with stability study management
Implement Global Standards and Processes for Stability Study Management and Continuous Improvement Projects within the Department
Coordination and Management of stability activities at external contract organizations (CMO,CTL, CRO) including procurement activities
Other Responsibilities and Projects as assigned
Bachelor's Degree in Science or Engineering
Experience in GMP regulations and compliance requirements
Knowledge and ability to author stability CMC sections and regulatory responses
Experience with quality systems (investigations, CAPAs, change controls)
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
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 posting excludes Colorado applicants.
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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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