Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Control Manager for Cell Therapye in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Control Manager working on the Investigational Medicinal Product Quality Advanced Therapies team, you will be empowered to lead the overall cGMP compliance, operation, and continuous improvement of internal Cell Therapy QC laboratory which is manufacturing Investigational Medicinal Product (IMP) utilized in Takeda clinical studies, and a typical day will include:
- This position supports internal QC testing as well as management of contract testing laboratories.
- This position is responsible for start-up activities for the QC lab and establishment of quality system.
- Supervise / lead internal QC analyst / support staff.
- Manage and conduct incoming component/raw material inspection/testing, in-process testing, and product release testing to support the manufacturing of cell therapy drug product manufactured in the internal GMP facility.
- Manage contract testing laboratories associated with QC testing for the IMP manufactured at the internal GMP facility.
- Issuing certificate of analysis of the IMP manufactured at the internal GMP facility.
- Ensure that testing schedules are achieved to provide timely analytical services for the testing of the IMP
- Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
- Manage laboratory equipment qualification and maintenance.
- Implement and maintain standards of safety to ensure the QC lab kept clean, safe and tidy all the times.
- Supervise analysts in the QC lab.
- Work closely and collaboratively with cross-functional team (e.g. QA, microbiology QC lab, production team, analytical development scientists) as the Quality Control Lead.
- Additional duties as assigned.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s Degree in Biology, Chemistry or another relevant field. Masters preferred.
- Minimum of 7 years experience in the bio/pharmaceutical industry
- Minimum of 5 years experience in GMP QC/laboratory with increasing responsibility
- Thorough knowledge of GMPs and current FDA & EMEA regulations, especially focused on clinical-stage development
- Experience of leading other QC analysts and scheduling daily activities
- Strong analytical knowledge and techniques, and practical experience with cell therapy methods (e.g. cell based-potency assay, flow cytometry, cell count, q-PCR)
- Experience with writing and reviewing SOP s for QC laboratories
- Previous experience in setting up a new QC laboratory is desirable
- Knowledge and experience of Lean Laboratories is preferable
- Excellent organizational, communication, interpersonal and report writing skills
- Demonstrable experience managing, motivating and leading a team
- Ability to adapt to changing priorities
- In general, the position requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs.
- This role supports pharmaceutical production operations therefore the work environment may include exposure to production and cell processing facilities, packaging, component printing and analytical laboratories (this list is not exhaustive).
- Requires approximately 10% travel, both domestic and international.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- 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
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.