The Senior Manager, QC Flow Cytometry is responsible for all operational aspects of the QC Flow Cytometry department at the CAR T manufacturing facility during clinical and commercial phases. This department is responsible for Flow Cytometry based testing of in-process samples, final drug product testing, stability testing, Validation and requalification support, critical reagent testing and qualification, training and other critical support as needed. The Senior Manager QC Flow Cytometry is responsible to act as the SME during regulatory inspections.
Required Competencies: Knowledge, Skills, and Abilities
- Extensive experience with flow cytometry and cell imaging, including flow related technologies related to analysis
- Advanced knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
- Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences
- Ability to collaborate cross functionally to drive operational and quality excellence.
- Advanced organizational and time management skills.
- Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
- Advanced teamwork and facilitation skills.
- Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
- Requires strategic thinking and ability to work independently.
- Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.
- Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Assessments.
- Ability to interpret and author general, technical, and complex business documents.
- Advanced knowledge and implementation of data integrity principles.
- Ability to represent the department in regulatory inspections.
- Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance.
- Proficiency in MS Office applications.
Duties and Responsibilities:
Manages all activities related to the QC Flow department including:
- GMP release of in-process and drug product testing results.
- Documentation of GMP release activities.
- Method development and validation.
- Oversight and qualification of contract testing laboratories.
Manages and develops direct reports including:
- Management and scheduling of personnel within the department to meet manufacturing and laboratory schedules and needs.
- Ensuring employees are properly trained and qualified to perform their assigned tasks, providing performance evaluations, and supporting career development of direct reports.
Performs other tasks as assigned.
Education and Experience
- Bachelor’s degree required, preferably in Chemistry, Microbiology, or related science.
- Master’s degree preferred.
- 9 years of relevant Quality Control work experience required, preferably in Flow Cytometry.
- 3 years of leadership experience with direct reports required
- Experience auditing suppliers.
- The incumbent will be required to work in office and laboratory environments.
- Ability to work extended hours, weekends, and holidays as required.
· The incumbent may be required to gown for entry into the Aseptic Core and other supporting areas on an as-needed basis.
· The incumbent (or designee) will be expected to be on call to support manufacturing issues involving sampling and/or test excursions or questions during shift operations.
· Occasional travel may be required.