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Industry: Research Services
Company Size: 51-200 employees

Tap Growth ai

Savvy Admin PROD

**Position **: Senior Scientist, Drug Product Development

**Duration **: 12-month contract

**Location **: Redwood City, CA

**Hybrid **: 3-4 days onsite, 1 day remote some flexibility

**Job Description**

**Senior Scientist, Drug Product Development**

**What you'll do:**

- Demonstrates technical proficiency, cross-functional collaboration with External Manufacturing, Process Development, Analytical Development, Quality Control, and other relevant stakeholders to drive improvement, consistency and compliance for drug product manufacturing processes.

- Establish internal Drug Product Development capabilities including:

- Design and conduct experiments to develop stable and effective drug formulations, including selection of excipients, and compatibility studies.

- Conduct stability studies to assess the short- and long-term integrity of drug products under various storage conditions and identify potential degradation pathways.

- Establish and qualify representative scale down models in support of drug product process design.

- Design drug product process characterization (PC) strategies, engage cross-functional SMEs and execute PC activities to enable BLA submission.

- Develop and scale-up manufacturing processes considering critical process parameters (CPPs) and critical quality attributes (CQAs). Utilize statistical analysis and experimental design to identify and improve process parameters, maximizing product yield and quality consistency.

- Provide support for drug product process technology transfer and GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, lead risk assessment and serve as person-in-plant as required.

- Manage, collaborate and provide scientific oversight of formulation and drug product process development and data generated by internal and contract labs.

- Must think critically, ability to work independently and awareness on when to seek guidance and have strong organizational and planning skills.

- Author and review technical development documents including study protocols, technical reports, and batch records.

- Provide direction and leadership to junior scientists.

**Requirements:**

- Ph.D. in Pharmaceutical Chemistry, Biochemistry, Chemistry, Chemical Engineering, Bioengineering or related discipline with 5-8 years of relevant experience in biologics or viral vector drug product development; or M.S. with 8-11 years of relevant experience. Job title is dependent on candidate’s experience level.

- Must have proven experience with formulation development, drug product process development and optimization, statistical design and analysis of experiment, managing CROs, tech transfer to CDMOs.

- Must have knowledge and hands-on experience with analytical instrumentation used in biologics/viral vector formulation and process development such as spectrometry, HPLC, CE, particle characterization techniques, calorimetry, light scattering etc.

- Experience with fill-finish processes, clinical compatibility studies, scale-up and/or technology transfer.

- Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.

- Knowledge of regulatory requirements and quality standards related to biopharmaceutical manufacturing.

- Must have excellent problem-solving skills, verbal and written communication skills.

- Ability to work in a dynamic environment, with a willingness to adapt to shifting priorities and tasks.

- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.

- Ability to work independently in a fast-paced startup environment as well as work collaboratively in a highly interactive team environment.

Senior Scientist

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