Location: Novato, CA 94949 (candidates should already be within a commutable distance at the time of application submission!)
Job Category: Quality
Department: QA Global Validation
Hours Per Week: 40.00
Type: 6-24 month W2 contractor thru Ascent- client known to convert 60% of their contract workforce every year but no guarantee! based on multiple factors such as performance, budgets and business need
Reason: Interim Worker (hired to cover FTE leave of absence)
10/8 Update: MUST HAVE: biologics drug substance process validation experience. (not looking for candidates with only CSV or devices/diagnostics exp.!)
This position will support completion of process validation projects related to the implementation of new manufacturing processes and changes to existing processes for drug substance manufacturing processes, drug product filling, process simulations (media fills), filtration, mixing, sterilization, lyophilization, vial & syringe filling, API chemical synthesis, blending, tableting, powder filling, and packaging, etc.
- The preferred candidate will have a general knowledge of the underlying scientific principles applied to the development and manufacture of biopharmaceuticals, and a keen interest in bioprocess operations. Experience with various stages of clinical and commercial manufacturing in a Quality and/or MSAT is preferred.
- Understanding and experience with change control, and Health Authority requirements is a plus.
- Organizes and performs process validation activities with minimal supervision within a cross-functional environment.
- The candidate will have a significant role in the approval of documentation and release of manufacturing systems and processes for cGMP use. This position is required to successfully complete projects in a timely manner supporting company goals and objectives.
- Collaborate with Process Sciences, MSAT, manufacturing, quality, and regulatory organizations to establish a reliable state of manufacturing process control.
- Perform process validation activities related to biologic/gene-therapy/small-molecule Drug Substance and Drug Products, through defined clinical and commercial stages.
- Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to establish acceptance criteria, and identify and implement solutions to meet client and Agency requirements.
- Author and/or review technical documents related to PV and PPQ deliverables, technology transfer, process monitoring, at-scale or scale-down studies, annual product reviews, and non-conformance (deviations/investigations) to support process transfer and ongoing manufacturing. Assist with preparation of regulatory filings.
- Provide a science-based approach for resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies
- Other responsibilities of this position include: protocol generation, protocol execution, final summary report generation, and other duties as assigned.
- Other duties as assigned.
- 3+ years of experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- Experience with several unit operations and systems used in the manufacture of drug substance and drug product.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of variable tiered audiences, and scientific disciplines.
- Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations.
- Technical writing skills are required for protocols and summary report generation.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
- Experience and proficiency with other applications (such as Trackwise, JMP, MS Access a plus).
- EDUCATION: Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
Key words: MSAT, validation; process validation, drug substance, drug product, aseptic filling, mixing, chromatography, science, protocols, reports, biologics, small-molecules, gene therapy