Job Title: Senior Engineer – Downstream Process Development
Job Number: 31128
Location: San Francisco, CA
We are seeking a Senior Engineer – Downstream Process (DSP) Development responsible for leading and executing downstream process development and process improvement activities in support of GMP pilot scale operations. Reporting to the VP of Bioprocess (BP), the scope of the role is primarily focused on cell culture harvest, cell-liquid separation, cell/tissue washing and sterile storage and handling technologies. This role is expected to work closely with our Upstream Process Development and Cell Line Development teams, follow methodical process optimization and scale-up approaches to generate results, and configure systems to comply with GMP guidelines. You are expected to keep abreast of new technologies and approaches, and strategically employ them into the development and implementation of a cost effective, robust and GMP compliant downstream processes.
- Develop, optimize, scale-up, and technology transfer robust and cost effective cell harvest processes into GMP pilot scale manufacturing operations.
- Develop project/study plans with clear goals, timelines, and resources.
- Lead and execute protocol-driven downstream process improvement studies through effective utilization of DoE methodology.
- Process characterization and support for validation activities
- Serve as the SME and contact person for all downstream process activities.
- Effective partnership with all stakeholders to accomplish the agreed upon goals.
- Contribute to the drafting of GMP production documentation, including SOPs and batch records with the Quality team.
- Full documentation of downstream process development and improvement activities according to appropriate Quality standards and in support of IP.
- Coordinate and execute the internal tech transfer to the GMP downstream operations.
- Align functional outputs with developments in Regulatory and Quality guidance.
- Ensure data integrity and scientific rigor in R&D experiments.
- Support of regulatory filings and regulatory audits as appropriate.
- Maintain awareness of cGXP, good scientific practices, monitor and promote lab and office safety.
- Passionate about our goal of building a more sensible food system.
- Combination of academic qualification and appropriate experience in biotech industry. e.g., B. Sc. in Bioprocess Engineering or Biological Sciences and 6+ years, or Ph.D. and 2+ years.
- Protein/cell harvest experience (e.g., filtration, centrifugation) in MSAT or R&D functions.
- Proven knowledge or expertise of DoE/statistical analysis.
- Organizational agility excellent written and communications skills
- Flexible and adaptable to pace and pivots of the startup world
- Motivational leader, team player exemplifying integrity, trust, and positive spirit
- Hands on commercial-scale GMP downstream experience particularly cell culture harvest/separation technologies (e.g., filtration, centrifugation, solid-liquid separation processes).
- Experience in business aspects of bioprocess engineering, including, but not limited to, vendor relations
- Experience in regulatory and quality considerations, including, but not limited to, QbD, FMEA, and establishment of key and critical process documents (e.g. CCP and CQA)
- Experience in food processing equipment and regulations
- Experience in Good Automated Manufacturing Practices
- Business Acumen