Quality Assurance Scientist (Analytical Methods) – Gene Therapy/Top $$
Our client, a clinical phase biotechnology company in the gene therapy space, is actively recruiting for a very sharp and knowledgeable scientist, with particular expertise in analytical method qualification and validation, to join its Quality Assurance team.
The company is in the process of building out its primary production facility in North Raleigh and ensuring the validity of its Analytical/QC Bioassay program is essential. Company will pay generously to attract and retain a star.
Key things to note:
- This company is developing immunotherapies based on its patented gene editing technology. It has numerous products in development – from discovery phase to early clinical.
- This QA Scientist will support the qualification of QC Bioassay activities including flow cytometry, ELISA testing, Polymerase Chain Reaction (PCR) testing, etc.. Substantial experience in noted techniques is expected.
- Position will also involve contributing to the development of policies and practices for CAPAs, Deviations, Change Control, etc. Seek Analytical Scientist with a strong QA bkgd.
- Familiarity with biologic or cell-based aseptic manufacturing processes will be important.
- This is a start-up environment. Ability to contribute to the development of validation strategies and tactics will be important. Extensive experience with method validation is expected
Specific responsibilities will include:
- Provide quality assurance input in the design, development, validation, and qualification of QC assay methods and lab systems.
- Ensure that validation and qualification activities are consistent with company validation policies and procedures and site validation master plan
- Perform compliance review and approval of analytical method qualification and validation protocols and reports for ELISA, FACS, potency, PCR, etc.
- Ensure method qualifications, method transfers, aseptic room qualification, environmental monitoring qualification and technical transfers meet company and regulatory requirements.
- Lead and participate in root cause identification and resolution (CAPA) for various types of quality related issues
- Review and approve investigation reports to ensure they contains the appropriate level of detail; and appropriate CAPA’s are identified
- Oversee and participate in the Change Control process including the authoring, review, and tracking of Change Controls
- Author and/or review SOPs for cGMP compliance and compliance to corporate policies and procedures
- Represent Quality Assurance on project teams to assure that quality objectives are met
Targeted candidate will offer a related scientific degree and 5+ years of QA/Analytical experience in a biopharmaceutical company. Substantial experience with flow cytometry and FACS is required.
Other priorities include:
- Familiarity 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, cytometer, etc.
- Substantial experience with method development and validation, change control, investigations, CAPAs, etc.
- Experience writing Standard Operating Procedures
- Knowledge of current global initiatives including Quality by Design, Process Validation and Data Integrity
- Longevity and impact in previous roles
Finally, we seek a highly collaborative and industrious professional who will thrive in this emerging and dynamic setting. A lot is happening. We seek an energetic and mission-driven builder who will contribute broadly.
This is an immediate need and a Direct Hire opportunity. Please forward Word resume for prompt consideration.
Local candidates only.