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Associate Director, Cell Therapy Microbiology QC
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Cell Therapy Microbiology QC in our Lexington, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment tocreate better health for people, brighter future for the world.
- The Associate Director, Cell Therapy Microbiology QC, is responsible for overall cGMP compliance, operation, and continuous improvement of an internal Microbiology QC laboratory as well as the contamination control program for a clinical-stage cell therapy manufacturing facility.
- This role provides subject matter expertise and sets the strategies for the facility in regards to aseptic processing simulations, gowning, contamination control of cleanrooms, and related microbiological activities and testing.
- The Associate Director, Cell Therapy Microbiology QC is directly responsible for a team of Microbiology QC subject matter experts and manages Microbiology QC operations which support development, manufacturing and compendial testing of innovative cell therapies.
- Accountable for management and operation of the Microbiology QC laboratory in the R&D Cell Therapy Manufacturing Facility. This includes but is not limited to managing compendial testing according to both cGMP requirements and Takeda quality standards, ensuring tests are executed in accordance with written procedures and test methods, robust training is established and completed, and test performance and results are promptly reviewed.
- Lead efforts, in collaboration with other site and company experts, to ensure compliance and adequacy of cleanroom design, airflow and pressurization control, cleaning and disinfecting, aseptic gowning, aseptic techniques and behavior, incoming raw materials control, and utilities monitoring and control.
- Provide leadership in the planning and management of environmental monitoring performance qualifications, routine environmental monitoring programs and related plans, protocols, reports, SOPs and other relevant GMP documents.
- Provide strategic direction and expertise for investigations into microbiological-related Out of Specification (OOS) or Out of Trend (OOT) analytical results, deviations, and investigations, as well as implementing corrective & preventive actions.
- This leadership position with direct reports, a core function of the role pertains to the effective recruitment, onboarding, development, management, motivation and retention of employees.
REQUIRED EDUCATION AND SKILLS:
- Bachelor’s Degree in Microbiology, Biology or another relevant field. Masters preferred.
- Minimum of 10 years of experience in the biotechnology or related industry, with at least 8 years of Quality Control/cGMP experience.
- Specific experience with cell or gene therapy is required.
EEO Verbiage for US Reqs
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.