Cell Therapy QA Manager (Manufacturing Operations)応募後で応募 求人ID R0067789 掲載日 05/20/2022 Location:Boston, Massachusetts
Job Title: Cell Therapy QA Manager (Manufacturing Operations)
Location: Cambridge, MA
About the role:
- The Cell Therapy QA Manager:
- Leads and executes GMP QA operational activities associated with Takeda’s internal GMP cell therapies manufacturing facility
- Is responsible for ensuring compliance to regulations and Takeda procedures for internal cGMP manufacturing and testing of clinical-phase cell therapy programs
- Directly manages the development, implementation, and maintenance of cGMP quality operational processes which support clinical-phase cell therapies.
- This role is specifically focused on GMP QA support for manufacturing operations.
How you will contribute:
- Employ GMP QA expertise and principles during the development, manufacturing, testing and disposition of clinical-phase cell therapies to ensure product quality and achieve business goals.
- Serve as GMP QA subject matter expert responsible for well-documented and compliant resolution of deviations, investigations and CAPAs in field of responsibilities.
- Effectively interact with quality team members and internal stakeholders to support site goals, projects, and issue resolution.
- Manage internal quality improvement initiatives in responsible area: evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs.
- Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance in field of responsibilities.
- Issue, review and approve GMP documentation (e.g., batch records, SOPs, job aids) needed for internal manufacturing operations.
- Review batch record documentation, ensure compliance and accuracy and make final disposition decision of cell therapy investigational material for use in Takeda-sponsored clinical studies.
- Engage in daily onsite quality oversight and guidance and collaborate across functions, leveraging quality and manufacturing expertise to troubleshoot problems, interpret data, and apply risk-based approach for ongoing manufacturing operations and related quality events.
- Additional duties as assigned.
Technical/Functional (Line) Expertise
- Demonstrated knowledge of current GMP regulations associated with pharmaceuticals, cell therapies, gene therapies, etc. in field of responsibility.
- Understanding and working knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions and respond rapidly to emerging quality situations. in field of responsibility.
Decision-making and Autonomy
- Ability to provide guidance to stakeholders and carry out tasks independently.
- Ability to independently distinguish between criticalities of quality issues and identify issues or topics for management escalation independently. Able to clearly articulate issues in a timely manner.
- Experience working in a biopharmaceutical development/production environment.
- Demonstrated teamwork, initiative, and problem-solving skills.
- Constructively work on teams in a complex, matrixed environment & maintain good working relationships with stakeholders.
- Ability to read, analyze and interpret common scientific and technical documents/information.
- Effectively presents information to management, internal groups and stakeholders.
- Highly organized and high attention to detail.
- Flexible and adaptable in a high pace environment.
What you bring to Takeda:
- Minimum requirements:
- Bachelor’s Degree in Biology, Microbiology, Chemistry or related field
- 4+ years of experience in cGMP Quality Assurance
- Preferred requirements:
- Master’s Degree in Microbiology, Biology, Chemistry or related field
- Working knowledge of cell or gene therapy product testing, manufacturing or development
This role supports biopharmaceutical production operations therefore the work environment may include exposure to production and cell processing facilities and analytical laboratories (this list is not exhaustive).
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
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.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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.