Principal Associate Scientist - Pharmaceutical Development

About the role

A healthier future drives us to innovate, ensuring everyone has access to the healthcare they need. As part of Pharma Technical Development (PTD), this role contributes to delivering game-changing therapies from clinical phase I to market. The Principal Associate Scientist ensures robust clinical and commercial parenteral drug product process designs for effective process validation and successful commercialization.

This position involves hands-on work at laboratory, pilot plant, and commercial scales for process development, scale-up, technology transfer, and troubleshooting. Examples of pharmaceutical processing include DP liquid filling and finishing, prefilled syringe, drying technologies, bulk freezing and thawing, sterile filtration, mixing, and primary container packaging development.

You will collaborate with formulation scientists, device engineers, and manufacturing staff to conduct drug product process development and perform technology transfers to internal and external CMO sites. This role supports globally harmonized strategy deployment and ensures right-first-time clinical and launch technology transfers. You will also contribute to new technology assessments, patent applications, manuscripts for external publication, and presentations at conferences.

Responsibilities

• 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 de-risk 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, and SOPs.
• Execute development and qualification studies, technology transfers, and new technology investigations.
• Interact with project teams and leadership to communicate results and drive projects.

Requirements

• B.S. in chemical engineering, pharmaceutical sciences, chemistry, bioengineering, or a related engineering discipline with 2+ years of relevant industry experience.
• Ability to translate expertise in chemical engineering, chemistry, and biology into a first-principles understanding of DP processes and the underlying chemistry.
• Excellent analytical and problem-solving abilities, with hands-on experience in protein processing, lab techniques, and instrumentation.
• Excellent written and verbal communication skills and the ability to interact and influence in a multi-disciplinary group setting.
• Knowledge of GMP documentation principles and relevant standards, guidance for industry, and regulatory statutes.
• Ability to contribute to several multi-faceted, cross-functional projects.

Preferred Qualifications

• Relevant biopharmaceutical industry experience.
• Expertise in process development for large molecule parenteral Drug Product pharmaceuticals.
• Demonstrated experience implementing processes in a clinical or commercial manufacturing facility.

Pay

The expected salary range for this position based on the primary location of South San Francisco, CA is $92,600 - $172,000. 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.

Benefits

This position qualifies for the benefits detailed at Genentech’s benefits page.