Principal Associate Scientist - Pharmaceutical Development

Posted Yesterday
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South San Francisco, CA, USA
In-Office
93K-172K Annually
Junior
Healthtech • Biotech
The Role
Develops and supports parenteral drug product processes from laboratory through commercial scale, including filling, filtration, mixing, freeze-thaw, lyophilization, sterilization, and packaging. Designs small-scale models, executes development and qualification studies, supports technology transfers and process validation, investigates new technologies, and troubleshoots manufacturing processes. Collaborates with formulation, engineering, quality, regulatory, commercial, manufacturing, and external CMO teams while authoring technical and regulatory documentation.
Summary Generated by Built In

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 Opportunity

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.

Who you are

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:

  • 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

Relocation benefits are not available for this job posting.

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.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

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 on the basis of 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 this form Accommodations for Applicants.

Skills Required

  • Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, bioengineering, or a related engineering discipline
  • 2 or more years of relevant industry experience
  • Ability to apply chemical engineering, chemistry, and biology principles to drug product processes
  • Strong analytical and problem-solving abilities
  • Hands-on experience with protein processing, laboratory techniques, and instrumentation
  • Excellent written and verbal communication skills
  • Ability to collaborate and influence in multidisciplinary groups
  • Knowledge of GMP documentation principles
  • Knowledge of relevant standards, industry guidance, and regulatory statutes
  • Ability to contribute to multiple multifaceted, cross-functional projects
  • Relevant biopharmaceutical industry experience
  • Expertise in process development for large-molecule parenteral drug products
  • Experience implementing processes in a clinical or commercial manufacturing facility

Genentech Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Genentech and has not been reviewed or approved by Genentech.

  • Healthcare Strength Health coverage is described as comprehensive across medical, dental, vision, mental health, and prescriptions, supported by HSAs/FSAs and broad wellness resources. On‑site fitness and health centers, mental‑health clinicians, and specialized programs like fully covered preventive cancer screenings and menopause support deepen the offering.
  • Retirement Support Retirement benefits feature a 401(k) with up to a 4% company match plus an additional annual 6% company contribution to eligible pay. Additional financial protections such as life and accident insurance complement salary, bonuses, and stock options.
  • Leave & Time Off Breadth Time away includes about 20 paid vacation days, paid holidays, personal days, and a year‑end shutdown. A paid six‑week sabbatical every six years notably expands long‑term time‑off flexibility.

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The Company
HQ: South San Francisco, CA
20,069 Employees
Year Founded: 1976

What We Do

Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 40 years. Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. We're passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal. Making a difference in the lives of millions starts when you make a change in yours.

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