Join our Oceanside MSAT (Manufacturing Science and Technology) Process Sciences team, where you will drive small and pilot-scale operations, process validation, and technology transfers in a multi-product biopharmaceutical facility.
As a Senior Engineer/Scientist, you will serve as a technical leader bridging late-stage process development with commercial scale, advancing vital biopharmaceutical manufacturing. This role offers a unique opportunity to lead cross-functional projects, implement cutting-edge technologies, and directly impact our site's operational excellence.
The Opportunity:
- Lead technical transfers of phase III molecules from late-stage development to commercial launch scale, including facility fit and scale-down model verification.
- Execute and lead small/pilot-scale process validation studies, routine testing, and investigations to support make-assess-release and network initiatives.
- Direct process scale-up activities, feedstock generation for downstream studies, and harvest parameter range evaluations.
- Perform, coordinate, and oversee upstream, downstream, and analytical small/pilot-scale operations, including bioreactor setup, inoculation, harvest, and cleaning.
- Drive troubleshooting for complex equipment and processes while spearheading continuous process improvement and new technology implementation.
- Act as the key technical liaison between Operations and Process Sciences customers, ensuring seamless communication across site networks.
- Record, analyze, and present complex experimental data clearly and confidently to multidisciplinary technical teams and key stakeholders.
- Train and mentor technicians and support personnel while leading independent, cross-functional projects from inception to implementation.
Who you are:
- Education & Experience: You hold a Bachelor's, Master's, or Ph.D. degree in Chemical/Biochemical Engineering or Life Sciences with 4–6 years of relevant experience in biopharmaceutical manufacturing.
- Technical Expertise: You demonstrate proficiency in biopharmaceutical manufacturing theories, core regulatory requirements, and practical application in process engineering.
- Execution & Problem Solving: You are self-driven with strong operational and technical troubleshooting skills, capable of managing projects independently from idea inception to execution.
- Collaboration & Communication: You exhibit excellent oral and written communication skills with a proven track record of collaborating effectively across multi-disciplinary teams and external partners.
- Flexibility & Accountability: You take ownership of deliverable timelines, adapt work approaches to meet run schedule demands, and show high attention to detail.
Preferred:
- Solid understanding of CHO cell culture processes and hands-on experience operating analytical instruments.
- Working knowledge of process control, manufacturing execution systems (MES), and enterprise resource planning (ERP) systems.
- Experience commissioning equipment, performing Factory/Site Acceptance Testing (FAT/SAT), and working in cleanroom environments requiring specialized gowning.
Relocation benefits are available for this posting.
The expected salary range for this position based on the primary location of California is $78,900 - $146,500 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.