Senior Engineer/Scientist

F. Hoffmann-La Roche AG; Oceanside (CA); On-site; USD 79,000 - 147,000; Full time

Job summary

Genentech Oceanside site seeks a Senior Engineer/Scientist to bridge late-stage development with commercial scale in a multi-product biopharmaceutical facility. You will lead technical transfers, run small/pilot-scale validations, and drive process scale-up and improvements.

You will direct upstream and downstream operations, coordinate testing, and mentor staff while ensuring regulatory compliance and cross-functional collaboration across site networks.

Qualifications

• Bachelor's/Master's/Ph.D. in Chemical/Biochemical Engineering or Life Sciences.
• 4–6 years of biopharmaceutical manufacturing experience.
• Strong problem-solving and independent project execution.
• Excellent written and verbal communication across disciplines.
• Experience with CHO cell culture preferred.
• FAT/SAT experience and cleanroom operations knowledge.

Responsibilities

• Lead technical transfers of phase III molecules from development to commercial scale, including facility fit and scale-down verification.
• Execute and lead small/pilot-scale validation studies and investigations to support release and network initiatives.
• Direct process scale-up activities and harvest parameter range evaluations.
• Oversee upstream, downstream, and analytical small/pilot-scale operations (bioreactor setup, inoculation, harvest, cleaning).
• Drive troubleshooting for complex equipment and processes; lead continuous improvement and new technology implementation.
• Serve as liaison between Operations and Process Sciences customers across site networks.
• Record, analyze, and present experimental data to multidisciplinary teams; mentor technicians and project personnel.

Skills

Biopharmaceutical manufacturing

Process engineering

Troubleshooting

Cross-functional collaboration

Regulatory knowledge

CHO cell culture

MES

ERP

Cleanroom operations

Education

Bachelors/Masters/PhD in Chemical/Biochemical Eng or Life Sciences

Tools

MES

ERP

Analytical instruments

Bioreactors

Job description

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 hand-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.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.