Parenteral Drug Product Process Engineer Scale-Up

Roche; South San Francisco (CA); On-site; USD 93,000 - 172,000; Full time

Benefits offered by this job

Benefits

Discretionary annual bonus

Job summary

Genentech, a member of the Roche Group, is seeking a Principal Associate Scientist in South San Francisco, CA. You will develop and optimize Drug Product processes, perform technology transfers, and collaborate with cross-functional teams to advance from clinical phase I to launch-ready manufacturing.

The role emphasizes hands-on lab work, process development, and contributing to efficient transfer and scale-up of biopharmaceuticals with GMP-driven documentation and quality standards.

Qualifications

• BS in chemical engineering, pharmaceutical sciences, chemistry, bioengineering or related engineering discipline.
• Ability to translate expertise into a first principles understanding of DP processes.
• Excellent analytical and problem solving abilities, hands-on experience with protein processing, lab techniques, and instrumentation.
• Excellent written and verbal communication skills and the ability to interact in a multi- disciplinary group.
• Knowledge of GMP documentation principles.
• Knowledge of industry standards, guidance for industry, and regulatory statutes.

Responsibilities

• Develop and support Drug Product processes and technology including freeze/ thaw, mixing, filtration, filling, lyophilization, sterilization.
• Design appropriate small scale models to understand mechanisms and derisk at-scale processes.
• Interact and collaborate with other functions including PTD, Quality, Regulatory, Commercial, and Manufacturing organizations in cross-functional projects.
• Author, review, and approve internal technical, development, validation, and manufacturing documents, including protocols, reports, exceptions, regulatory filings, SOPs etc.
• Execute development and qualification studies, technology transfers, and new technology investigations.
• Interact with project teams and leadership to communicate results and drive projects.

Education

BS in chemical engineering, pharmaceutical sciences, chemistry, bioengineering or related engineering discipline

Job description

Genentech, a member of the Roche Group, is seeking a Principal Associate Scientist in South San Francisco, CA. You will develop and optimize Drug Product processes, perform technology transfers, and collaborate with cross-functional teams to advance from clinical phase I to launch-ready manufacturing.

The role emphasizes hands-on lab work, process development, and contributing to efficient transfer and scale-up of biopharmaceuticals with GMP-driven documentation and quality standards.