Job Title: AD/Director of Bioprocess Innovation
Job Number: 31127
Location: San Francisco, CA
We are seeking a highly talented AD/Director of Bioprocess Innovation (BPI). This role plays a pivotal part in our Bioprocess team. You will craft our bioprocess innovation strategy, develop the roadmap for next generation technology platforms, and take the cell culture processes to a more cost effective and robust level. Your creativity and energy will have a direct and long term impact on the business.
Reporting to VP of Bioprocess, the primary focus will be scouting and developing new bioprocess technologies in upstream, downstream, media development and optimization, in-process analytics, process control, next generation process modes (e.g., fed-batch, perfusion system, cell separation technologies, etc.), as well as scale up, and technology transfer to GMP manufacturing. This role is expected to establish value-added external and internal partnerships and collaborate with vendors and research institutes to assess, develop and implement innovative solutions into GMP manufacturing operations. You will work closely with the Process Development and Cell Line Development teams, follow methodical process optimization & scale-up approaches to generate results, and maintain full alignment with the senior leadership team and the overall vision. Ultimately, this role will translate the bioprocess vision into optimized, cost effective, GMP compliant, and uninterrupted cell cultured meat production.
The ideal candidate will display teamwork, full alignment with strategic plans and agreed upon priorities, and passion for our mission, expected to keep abreast of new technologies and approaches, strategically employs these into the development, optimization, and implementation of a cost effective, robust and GMP compliant bioprocesses.
- Scout, assess, develop and implement new technology platforms in various bioprocess areas such as but not limited to upstream, downstream (e.g., cell harvest), media optimization, high throughput process optimization, scale up/down, process analytical technology (PAT), and process control strategies geared towards robust and cost effective GMP pilot scale manufacturing processes.
- Spearhead planning and executing strategic projects to develop next generation upstream, bioreactor design, and downstream systems to improve yield and reduce COGs.
- Lead and execute protocol-driven process tech assessment and improvement studies through effective utilization of DoE methodology.
- Build a team of highly skilled scientists and engineers.
- Lead career development plans, mentor, and provide clear directions to meet functional and strategic team goals.
- Develop project/study plans with clear goals, timelines, and resources. Partnership with all stakeholders (internal and external) to accomplish the agreed upon goals.
- Align functional outputs with developments in Regulatory and Quality guidance.
- Full documentation of process development and improvement activities according to appropriate quality standards and in support of IP.
- Ensure data integrity and scientific rigor in R&D experiments.
- Support 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.
- Ph.D. in Bioprocess Engineering or Biological Sciences and 5+ years of hands on and leadership experience in the biotech industry, or MSc with +8 years of relevant experience.
- Technical knowledge and hands-on experience in cell culture expansion, bioreactor process design/control, upstream process development, and cell harvest.
- Proven knowledge or expertise of DoE and statistical analysis.
- People leadership in an innovative team setup.
- Proven record of leading innovative bioprocess projects into implementation.
- Mindful of and up to date with the current bioprocessing technology trends.
- Experience in regulatory and quality considerations, including, but not limited to, establishment of Critical Process Parameters and Critical Quality Attributes, Chemistry, Manufacturing, and Controls compliance, and Biologics License Application submissions.
- Organizational Agility
- Excellent Written and Communication Skills
- Hands on cell culture or fermentation pilot scale experience.
- Record of building collaboration and external partnerships.
- Business acumen, innovation, and quality problem solving
- Experience in business aspects of bioprocess and/or tissue engineering, including, but not limited to, vendor relations and budget management.
- Experience in food processing equipment and regulations.
- Experience in functionalizing and/or tech transferring GMP processes
- Experience in Good Automated Manufacturing Practices