Biopharma Process Scientist - Scale-Up & Tech Transfer Lead

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

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.