Senior Scientist I, Drug Product and Device Development

Role Summary

Senior Scientist I in Drug Product and Device Development. Lead formulation development for liquid and lyophilized biologics, support clinical-stage process development and manufacturing initiatives, and serve as the scientific representative on cross-functional program teams. Location is San Francisco with an expectation of at least 3 days per week in office.

Responsibilities

• Scientific leadership of formulation development and process optimization for parenteral dosage forms of monoclonal antibodies and biologics, ensuring robustness, stability, and scalability
• Design and execute in-house laboratory studies, including formulation screening, in-use stability studies, and analytical characterization, leveraging advanced experimental designs (DoE) and statistical methods
• Provide technical direction and oversight for internal and external drug product development and manufacturing activities, including data review, trouble-shooting, and risk assessment
• Lead technical transfer of manufacturing processes at contract manufacturing organizations, managing cross-functional alignment and proactively addressing challenges
• Author and review high-impact technical reports, regulatory submissions, and scientific publications, ensuring clarity, accuracy, and regulatory compliance
• Represent Drug Product and Formulation and Device Development on cross-functional program teams, actively contributing to strategy, timelines, and issue resolution in collaboration with clinical, process development, analytical, quality, and regulatory stakeholders
• Ensure consistent scientific oversight for data generated by internal teams and contract research/manufacturing organizations, upholding best practices and industry standards
• Drive continuous improvement initiatives and implement new technologies or methodologies to strengthen group capabilities

Qualifications

• Required: PhD with 5+ years, or Master’s with 8+ years, or Bachelor’s with 10+ years’ experience in Biosciences, Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering, or related discipline
• Required: Demonstrated expertise in formulation and drug product development for monoclonal antibodies and biologics; hands-on experience with lyophilization and prefilled syringe development strongly preferred
• Required: Proficiency in experimental design (DoE), data analysis, and use of statistical programs for formulation screening and optimization
• Required: Strong working knowledge of analytical methods supporting formulation assessments
• Required: Solid understanding of pharmaceutical development, particularly as related to biological drug development
• Required: Experience authoring development reports, batch records, SOPs, regulatory filings, or other documents
• Required: Previous experience representing Drug Product and formulation on inter-disciplinary teams and with external collaborations
• Required: Experience leading technical projects and mentoring junior team members

Education

• PhD with 5+ years, or Master’s with 8+ years, or Bachelor’s with 10+ years’ experience in a related biosciences/tech field

Skills

• Experimental design (DoE) and data analysis
• Analytical methods for formulation assessments
• Regulatory documentation and cross-functional communication