Principal Scientist, Biologics Pivotal Formulation and Process Development

$191,335 - $247,610/Yr

Gilead Sciences - Foster City, CA

Full-time - Principal

Foster City, CA

Chemical Manufacturing

About the position

The Principal Scientist, Biologics Pivotal Formulation and Process Development role at Gilead Sciences is a key position within the CMC development team, focusing on advancing biologics medicines into clinical stages. The successful candidate will leverage their technical expertise to lead drug product development efforts, contribute to strategic initiatives, and collaborate across functions to ensure regulatory compliance and innovation in drug formulation and manufacturing processes.

Responsibilities

• Design and execute formulation and drug product process development work packages for biologics.
• Demonstrate deep understanding of analytical, biophysical characterization, or process development techniques.
• Embrace data integrity and good documentation practices for data and report generation.
• Work with functional leaders to develop a functional handbook for business process and technical excellence.
• Represent function and collaborate on cross-functional teams to support project strategy and regulatory filings.
• Drive innovation and grow technical expertise through publications and presentations.
• May coach direct reports.

Requirements

• Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields with a minimum of 5 years experience, OR M.S. with 8+ years, OR B.S. with 10+ years of industrial experience in biologics CMC development.
• End-to-end experience of biologics formulation and process development, including early- and late-stage development.
• Experience of IND and/or BLA fillings.
• Expertise in lyophilization cycle development and GMP drug product fill and finish.
• Working knowledge of lab automation, data science, and knowledge management.
• Hands-on lab execution experience and training of junior members.
• Publication and external presentation track records demonstrating strong technical innovation capabilities.

Nice-to-haves

• People management experience is strongly desired.
• Experience working with contract development and manufacturing organizations is highly preferred.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus eligibility.
• Discretionary stock-based long-term incentives eligibility.
• Paid time off.