Process Development and Process Engineer
Reports to TBD
Full time. Weekends or weeknight work occasionally required depending on production schedule or process needs.
The Process Development (PD) and Process Engineer will be responsible for developing scale up manufacturing processes and provide operational support to equipment and systems in the manufacturing of clinical products at Vyriad under GMP. The candidate should be experienced in large scale or commercial manufacturing, and has function covers all equipment and systems related to: cell expansion, both fixed bed and stir tank bioreactor operations, clarification, downstream processing of tangential flow, diafiltration systems, chromatography technologies, large scale media/buffer solution preparation, custom skids and systems, bench top process analytics and technology, good engineering practices (procedures and standards for engineering lifecycle covering requirements, specification & design, verification, acceptance & release).
- Responsible for manufacturing scale-up activities to support late-stage clinical trials and commercialization of viral-based therapeutics.
- Establish and implement process improvement plans (upstream and downstream processes, purification, formulation) with staff members.
- Drive technology transfer of PD activities to ongoing cGMP drug product manufacturing including process qualification and validation.
- Troubleshoot root cause of problems and provide optimization strategies for process equipment.
- Ensure highly complex pieces of process equipment and systems remain within their validated state and regulatory compliance.
- Candidate will be the primary liaison between Manufacturing, Facilities and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of process equipment for cGMP production facilities.
- Author protocols, reports, risk assessments, SOPs, and batch record worksheets.
- Use technical experience to troubleshoot issues with drug substance/product processing technologies and equipment.
- Must be able to work in a fast-paced multi-disciplinary environment.
- Serve as a subject matter expert to support manufacturing operations.
- Drive continuous improvement in our cGMP process through technological innovation and application of experimental findings.
- Lead functional and cross functional teams to achieve company goals.
- Keeping up to date with current technologies and trends in drug product processing.
- Additional duties or responsibilities as assigned by supervisor.
- Advanced degree (Ph.D. and/or graduate degree) in an engineering field or science related field with 5+ years of related work experience or a Bachelor’s degree in a science related field with 8+ years of related work experience. All candidates must have a minimum 4 years working in biologics drug products.
- Personnel management experience is required.
- Experience in single use manufacturing technologies, conducting process characterization, analysis and development with minimal supervision and aseptic manufacturing processes in ISO 5, 6 and 7 environments is required.
Experience and Skill Requirements
- Experience with large scale (>500L bioreactor) mammalian cell culture, viruses and viral vectors, and viral purification (tangential flow filtration, diafiltration, chromatography) strategies strongly preferred.
- Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing and testing is required. Experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
- Exceptional communication (written, verbal, and listening) skills are required.
- Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
- Strong analytic skills coupled with critical thinking skills are essential in this role.
- Must have demonstrated capacity to write and comprehend complex protocols and reports, programs, and situations.
- The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required.
- Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.