Sr. Manager/Manager, Quality Control
The Senior Manager/Manager, Quality Control will provide support for analytical methods in clinical stage manufacturing of NK cell therapy product. Responsible for phase appropriate validation of bioanalytical methods, in-process, final product testing, stability testing, upkeep/maintenance of QC instrumentation and lab in GMP compliance. This individual will work with outside testing labs and other NKGen Biotech sites for method transfers and accountable for managing QC projects with timelines.
- Manage the transfer and validation of analytical methods to NKGen Biotech, QC laboratories and for clinical stage product from Analytical Development. Validation of methods will be phase appropriate.
- Establish user requirements for purchase; qualification of NKGen Biotech’s QC analytical equipment and work with internal/external resources to maintain equipment in an optimal state.
- Responsible for OOS, lab and protocol deviations, and implementing corrective action plans when necessary, while providing updates at daily and weekly meetings.
- Support QC analytical team to sustain a scalable group to support multiple clinical programs.
- Assist in the preparation of dossiers and data packages for interactions between NKGen Biotech and Regulatory agencies.
- Assist in regulatory inspections and interact with Regulatory agencies and participate in Inspections.
- Review of records; generation of CoAs for product release. Complete routine record review of test data and related documents for in-process, and drug substance testing. Develop, revise and review SOPs.
- Responsible for QC’s training and monitoring the GMP systems currently in place, to ensure compliance with documented policies.
- Manage and conduct lab investigations, write deviations, and own change controls.
- Responsibility of data trending, control charts and metrics.
- Up to 10% domestic travel.
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- 8+ years of experience, with BS degree in Molecular Biology, Biochemistry, Biology or a related scientific discipline.
- 6+ years of experience with MS degree in Molecular Biology, Biochemistry, Biology or a related scientific discipline.
- Well-versed and experienced in bioanalytical methods and in managing a Quality Control laboratory under GMP compliance.
- Strong experience in various analytical techniques Flow cytometry, ELISAs, PCR, cell-based assay, and other applicable methods to the testing of viral vector and cellular therapy products.
- Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs. Knowledgeable regarding the requirements for analytical testing and phase appropriate qualifications and validations, at each stage of clinical development and product approval.
- Strong experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards
- Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change control.
- Ability to effectively negotiate and build collaboration amongst individuals.
- Demonstrated ability to develop, coach, and mentor key employees.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced, small company, environment with minimal direction and able to adjust workload based upon changing priorities.
- Shift and/or weekend work may be required
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!