Eastridge Workforce Solutions

in the search for a Principal Process Development Engineer.. This role will focus on understanding the key technologies, raw materials, and process needs to effectively scale the bioprocess towards manufacturing.. Candidates must be highly skilled in pilot-scale bioreactor operation, process scale-up strategies and design of experiments, statistical analysis, and communication of results.. Proficiency in bioprocess scale-up (fermentation or cell culture or equivalent) and expertise in developing and operating a variety of single-use and stainless-steel bioprocess equipment is required.. bioreactor hardware and SCADA systems including defining and understanding automation requirements to work closely with team members and service providers to design, implement and update automation code in bioprocess equipment.

process development engineer

Eastridge Workforce Solutions is partnering with a global leader in cell-cultured seafood. in the search for a Principal Process Development Engineer. Our client is an innovator in the seafood industry, providing consumers with great tasting, healthy, safe and trusted seafood products that support the sustainability and diversity of our oceans. They recently secured $33.5M in Series B funding and are on an exciting growth trajectory. This role will have a pivotal impact on the pilot phase of their manufacturing efforts. This is a full-time, direct hire position in San Diego, CA. Job Summary: The core responsibility of this position is to develop and optimize cell culture and recovery at pilot scale. This role will focus on understanding the key technologies, raw materials, and process needs to effectively scale the bioprocess towards manufacturing. Candidates must be highly skilled in pilot-scale bioreactor operation, process scale-up strategies and design of experiments, statistical analysis, and communication of results. Essential Responsibilities: Lead execution of development and optimization of pilot-scale cell culture. Design and implement cell culture scale-up strategies, spanning from pilot-scale working, when required, with external service providers (such as CROs or CDMOs), to achieve critical company goals and technological benchmarks. This would include leading small and effective teams on critical process development and technology transfer projects with internal and external teams and when required, perform on-site visits with external collaborators. Work cross-functionally with R&D, Engineering, Quality, and Operations to successfully transfer SOPs and related documents that meet target specifications. Evaluate new and existing bioprocess technologies, methods, and equipment with emphasis on scale-up and optimization of cell culture, media preparation and cell recovery. Serve as technical lead in discussions with service providers on conceptualization, design and construction of large-scale bioreactors and other upstream process equipment. Develop specifications, procedures, and testing protocols as required for bioprocess development and validation and assist in their execution. Facilitate industrial scale milestones that resonate with the quality standards Preparation of invention disclosures and other IP documentation as required. Collaborate, when required, with suppliers and vendors to effectively source materials and services. Minimum Qualifications: Principal Engineer: Applicants with a PhD and 8+ years of industry experience are preferred, MS with 10+ years of industry experience in the technology field. Senior Engineer: Applicants with a PhD and 5+ years of industry experience are preferred, MS with 8+ years of industry experience in the technology field. Proficiency in bioprocess scale-up (fermentation or cell culture or equivalent) and expertise in developing and operating a variety of single-use and stainless-steel bioprocess equipment is required. Proven experience working with contract manufacturers and service providers successfully transferring cell culture technologies and demonstrating performance from 10L to 100kL scales and leading engineering on-site visits at contract manufacturing and research facilities. Proven Experience in working with service providers to specify and design bioprocess equipment at pilot-to-manufacturing scale with understanding of the sizing, utility and control requirements required for effective functioning of the bioprocess systems. Accurately summarize, interpret, and review experimental data with adequate computer skills for data acquisition, data management and visualization of experimental results. Experience with independently developing procedural documentation and technology transfer protocols for bioprocesses. Prior experience managing individuals or small teams to achieve company's goals. Demonstrated strong background to lead technically driven projects, and ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects. Use of DOE and related software to design and analyze experiments. High level of initiative to solve problems and ability to multitask and ability to function effectively in a high performance-driven environment. Nice to Have: A history of innovation, creativity, and collaborations with mammalian cell culture and/or food fermentations. Hands-on experience and mechanical aptitude for troubleshooting and maintaining bioreactor hardware and SCADA systems including defining and understanding automation requirements to work closely with team members and service providers to design, implement and update automation code in bioprocess equipment. Experience working in a GMP environment (and related processes and documentation) is preferred. Benefits Comprehensive Medical Benefits, Equity, Work/Life Balance, Professional Development, Generous Time Off. Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants. We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply.Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. #IPROPLUS #LI-BL2

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