Technical Development Principal Engineer

Overview

This role is part of Pharma Technical Development and focuses on ensuring robust clinical and commercial parenteral drug product process designs for effective process validation and commercialization. The Principal Engineer works in the Laboratory, pilot plant, and commercial scale of biopharmaceutical processing facilities, providing design, scale‑up, technology transfer and troubleshooting for a range of processes including filling, lyophilization, filtration, and device development.

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

• B.S., M.S., or Ph.D. in chemical engineering, pharmaceutical sciences, chemistry, bioengineering or a related engineering discipline.
• 2+ years post‑Ph.D., 5‑6+ years post‑M.S., or 8+ years post‑B.S. with experience in biopharmaceutical industry.
• Expertise in process development for large‑molecule parenteral drug products with demonstrated experience implementing processes in a clinical or commercial manufacturing facility.
• Expert‑level ability to translate chemical engineering, chemistry and biology into first‑principles understanding of DP processes and underlying chemistry.
• Excellent analytical and problem‑solving abilities with hands‑on laboratory experience with protein processing, lab techniques, and instrumentation.
• Excellent written and verbal communication skills and the ability to influence a multi‑disciplinary group.
• Knowledge of GMP documentation principles, relevant standards, guidance for industry and regulatory statutes.
• Ability to manage several multi‑faced, cross‑functional projects.

Salary range (South San Francisco, CA): $120,800 – $224,300. Actual pay will be determined based on experience, qualifications, geographical location, and other job‑related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance.

Relocation benefits are available for this position.

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 based on protected veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing the accommodations form.