Scientist 2 - Pharmaceutical Development

F. Hoffmann-La Roche AG; South San Francisco (CA); On-site; USD 93,000 - 172,000; Full time

Benefits offered by this job

Discretionary annual bonus

Benefits package

Job summary

Genentech, a member of the Roche Group, is seeking a Technical Development Scientist 2 to ensure robust parenteral DP process designs for validation and commercialization. You will work across lab, pilot plant, and manufacturing scales, developing and transferring DP processes, collaborating with formulation scientists, device engineers, and production staff.

Preferred candidates have a background in DP processing, strong problem-solving abilities, and experience with GMP documentation.

Qualifications

• B.S. in chemical engineering, pharmaceutical sciences, chemistry, bioengineering or related field.
• 2+ years of relevant industry experience.
• Translate expertise in DP processes from chemistry/biology to first-principles understanding.
• Strong analytical/problem solving abilities and lab skills.
• Excellent written and verbal communication.
• Knowledge of GMP documentation principles.

Responsibilities

• Develop and support Drug Product processes including freeze/thaw, filtration, filling, lyophilization, sterilization.
• Design small-scale models to derisk at-scale processes.
• Collaborate with PTD, Quality, Regulatory, Commercial, and Manufacturing in cross-functional projects.
• Author, review, and approve internal technical and manufacturing documents.
• Execute development, qualification studies, technology transfers, and investigations.
• Communicate results and drive projects with project teams and leadership.

Skills

Chemical engineering knowledge

Analytical skills

Communication skills

GMP knowledge

Education

B.S. in chemical engineering / related field

Job description

About the role

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 Technical Development Scientist 2 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 Technical Development Scientist 2 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. The Technical Development Scientist 2 contributes to assessment of new technologies, activities related to patent applications and manuscripts for external publication, and presentations at conferences or meetings.

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

• 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.

Compensation

• Salary: $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.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life‑threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.