Principal Associate Scientist - Pharmaceutical Development

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.  Creating a world where we all have more time with the people we love. That’s what makes us Genentech, a member of the Roche Group! As part of Pharma Technical Development (PTD) our organization is committed to deliver the Pharma ambitions by bringing game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development. As an integrated partner within the drug development ecosystem, Global Biologics Pharmaceutical Development is dedicated to effectively developing innovative and patient-centered parenteral drug products including Formulation and Process Development and Drug Delivery Systems.

The Principal Associate Scientist ensures robust clinical and commercial parenteral drug product process designs for effective process validation and successful commercialization. This includes hands-on work at laboratory, pilot plant, and commercial scale of biopharmaceutical processing facility for process development, scale up, technology transfer and troubleshooting. Examples of pharmaceutical processing are DP liquid filling and finishing, prefilled syringe, drying technologies, bulk freezing and thawing, sterile filtration, mixing, primary container packaging development, etc. In this role, you are expected to work with formulation scientists, device engineers, and manufacturing staff to conduct drug product process development, perform technology transfers to internal and external CMO sites. The Principal Associate Scientist works within the Global Drug Product Process Engineering group to support the globally harmonized strategy deployment and ensure right-first-time clinical and launch technology transfers. Principal Associate Scientist contributes to assessment of new technologies, activities related to patent applications and manuscripts for external publication, and presentations at conferences or meetings. Your key responsibilities: Develop and support Drug Product pharmaceutical processes and technology including freeze/ thaw, mixing, filtration, filling, lyophilization, sterilization, etc.  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.

Our ideal candidate will meet the following criteria: 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, hands-on experience with 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. Knowledge of relevant standards, guidance for industry, and regulatory statutes.  Ability to contribute to several multi-faceted, cross-functional projects. Preferred: