Senior Scientist I, Drug Product and Device Development

Role Summary

Senior Scientist I to help advance Drug Product and Device Development. Lead formulation development for liquid and lyophilized formulations across biologic modalities, support for clinical-stage process development and manufacturing, and representation on cross-functional program teams. Role combines technical execution with leadership responsibilities in a San Francisco 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 DoE and statistical methods
• Provide technical direction and oversight for internal and external drug product development and manufacturing activities, including data review, troubleshooting, and risk assessment
• Lead technical transfer of manufacturing processes at contract manufacturing organizations, managing cross-functional alignment and 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, contributing to strategy, timelines, and issue resolution with stakeholders from clinical, process development, analytical, quality, and regulatory
• Ensure consistent scientific oversight for data generated by internal teams and external partners, upholding best practices and industry standards
• Drive continuous improvement initiatives and implement new technologies or methodologies to strengthen group capabilities

Qualifications

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

Skills

• Analytical method development and validation
• DoE and statistical analysis
• Cross-functional collaboration and technical leadership
• Technical transfer and project management

Education

• PhD, or Master’s or Bachelor’s degree in related discipline as specified