QC, Raw Materials Lab Supervisor (Start-up Biotech Facility) – Top $$/Raleigh
Our client, a clinical phase biotechnology company that is in the process of building out its primary facility in the North Raleigh area, is actively recruiting for a QC Raw Materials Supervisor. This supervisor will be responsible for developing and implementing quality control procedures for all incoming materials. Company will pay generously to attract and retain a start.
Key things to note:
- This is a gene therapy company that is developing immunotherapies based on its patented gene editing technology. It has numerous products in development – from discovery phase to early clinical.
- This supervisor will be responsible for risk assessment as well as building out the QC program. Experience developing raw materials analytical methods in a start-up setting will be important. Additional experience moving from clinical to commercial is highly preferred.
- This is an aseptic manufacturing process and familiarity with biologic or cell-based products is required.
- This supervisor will manage 2 analysts. Additional personnel expected in the near-term.
- Company engages contract testing labs. Experience overseeing the work of third party vendors is a must.
Position will involve developing and executing the QC Raw Materials strategies and tactics including incoming materials inspection, incoming materials testing, management of contract testing laboratories and compliant documentation. S/he will also be responsible for identifying and implementing ongoing quality improvement processes working with interdepartmental teams.
Responsibilities will include:
- Hires, develops, trains, manages and evaluates QC Raw Materials personnel
- Authors raw materials specifications, test methods and method validation/transfer protocols and reports
- Provides the Quality Inspection and release for all incoming raw materials
- Ensures compliance with applicable US and European CGMP regulations, corporate policies and company SOPs
- Provides input based on knowledge of QC Raw Materials used for cell/gene manufacturing, test procedures and CGMP issues including but not limited to the development of acceptance testing schemes as appropriate
- Develops Raw Materials analytical methods as needed
- Ensures timely issuance, review and approval of Raw Materials testing results
- Evaluates and investigates laboratory deviations and initiates and coordinates corrective and preventive actions
- Interfaces with colleagues to ensure CAPAs are implemented for any recurring product/process discrepancies
Targeted candidate will offer a related scientific degree and 5+ years of relevant Raw Materials experience in a biopharmaceutical company. Ability to perform risk assessments and develop testing plan (what, when, where) in a start-up setting will be critical. Other priorities include:
- Knowledge and experience with tests and techniques used for biologics including microbial load, microbial identification, endotoxin, sterility, cell culture, nutritional adequacy, aseptic technique, flow cytometry, ELISA, cell-based assays, potency testing, working in an isolator, etc.
- Experience with quality systems including change control, deviations, risk assessments, batch record review, batch release, and quality metrics as well as developing test methods including suitability studies for compendial methods and method validation for non-compendial methods
- Supervisory experience as well as experience overseeing the work of contract labs
- Knowledge of current global initiatives including Quality by Design, Process Validation and Data Integrity
- Knowledge of inspection and sampling plans utilized in the biopharmaceutical industry (e.g. ANSI/ASQ Z1.4-2008).
- Experience writing Standard Operating Procedures and Work Instructions
- Experience choosing equipment and instrumentation for the Raw Materials Laboratory
- Understanding of aseptic manufacturing
- Longevity and impact in previous roles
Finally and critically, we seek a highly collaborative and industrious professional who will bring the ingenuity, resourcefulness and flexibility needed to thrive in this emerging and dynamic setting. This is an exciting time at a very exciting company. We seek the energetic builder who will make things happen.
This is an immediate need and a Direct Hire opportunity. Please forward Word resume for prompt consideration.
Local candidates only.