Hiring company: Takeda
About the role:
The Manager, Cell Therapy Quality Assurance ensures compliance to regulations and Takeda procedures for internal cGMP manufacturing and testing of clinical-phase cell therapy programs. This position:
- Lead strategic GMP QA operational activities associated with Takeda's internal GMP cell therapies manufacturing facility
- Directly manage the implementation and maintenance of cGMP quality operational processes for clinical-phase cell therapies
- Independently manage projects related to product quality issues
How you'll make an impact:
- Employ GMP QA expertise and principles during the development, manufacturing, testing, and disposition of clinical-phase cell therapies to ensure product quality
- Review batch record documentation, ensure compliance and accuracy, and conduct final release disposition of cell therapy investigational material for use in Takeda-sponsored clinical studies
- Be a QA expert for internal GMP operations and in the resolution of deviations and out-of-specification investigations
- Approve raw material specifications
- Approve and release raw materials for internal manufacturing
- Manage internal quality improvement projects; evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs
What you bring to Takeda:
- Bachelor's Degree in Biology, Chemistry, Engineering, or related field
- 7+ years of experience in the biotech industry
- 5+ years of Quality/cGMP Compliance experience
- 1 year in cell therapy quality
- Specific experience in the following:
- Cell and gene therapy product manufacturing or testing
- Investigational medicinal products
- Experience working in an internal bio-pharmaceutical development environment
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 paid time off for vacation, sick leave, and volunteering
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Professional development and training opportunities
- Tuition reimbursement
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.
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
“This job posting exclude Colorado applicants.”
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.