Senior Quality Control Manager
4 weeks ago
We are seeking an experienced Senior Quality Control Manager to join our team at Neogene Therapeutics. The successful candidate will be responsible for managing samples, reagents, instruments, and stability programs for our QC Analytical laboratory, ensuring open communication channels to meet our needs.
Key Responsibilities- Manage samples, reagents, instruments, and stability programs for QC Analytical laboratory
- Work with Supply Chain and Manufacturing team to QC samples and reagent supplies for QC Analytical testing and guarantee release of drug products and execution of stability programs
- Execute and approve IOQ and repair documents of instruments
- Coordinate and design stability programs and ensure implementation of sample testing
- Ensure QC Analytical laboratory is operating as expected
- Partner with Facilities to coordinate QC Analytical equipment and instrument maintenance and calibration
- Manage lab supplies and set up proper procedures for sample management and GMP testing workflows
- Ensure laboratory housekeeping activities are completed to maintain QC Analytical laboratory in a state of compliance
- Lead or assist lab auditing and support analytical lab investigations
- 7+ years with BS/BA; 5+ years with MS; 2+ years with PhD in Biology, Biochemistry, Molecular Biology or other relevant field
- MS with 7 years of experience in quality control testing, analytical development, or GMP; OR a PhD with 5 years of experience is preferred
- At least 5 years of QC operation GMP experience and at least 3 years in a leadership role
- Flexibility of occasionally working in weekend or holidays to support lot release testing
- Work experience in a cGMP environment with supervisory responsibilities
- Experience authoring and reviewing Deviations, Investigations, CAPA and Change Control
- Demonstrate ability to collaborate, work, and organizational interfaces in a dynamic team setting
- Quick learning/application of concepts and information
- Identify OOS's and investigations
- Knowledge of cell culture techniques and proficient in Microsoft suite and other applications
- Familiar with equipment IQ/OQ/PQ in a QC setting
- Work in a self-guided manner with scientific/technical personnel
- Short-term incentive bonus opportunity
- Equity-based long-term incentive program
- 401(k) plan
- Paid vacation and holidays; paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage
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