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Senior Research Scientist I, Biologics Pivotal Formulation and Process Development
1010 Gilead Sciences, Inc. - Foster City, CA
posted 2 months ago
About the position
The Senior Research Scientist I, Biologics Pivotal Formulation and Process Development role at Gilead 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 projects, contribute to functional strategies, and collaborate with cross-functional teams to support regulatory filings. This role offers opportunities for career growth in a dynamic and resource-rich environment.
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.
- Fully 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 work collaboratively on cross-functional teams to support project team strategy and regulatory filings.
- Drive innovation and continuously grow technical expertise; influence through publication and presentations.
- May coach direct reports.
Requirements
- Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Science, or related fields with a minimum of 2 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 both early- and late-stage development experiences.
- Experience of IND and/or BLA fillings.
- Expertise in lyophilization cycle development and GMP drug product fill and finish is highly desired.
- Working knowledge of lab automation, data science, and knowledge management.
- Hands-on in lab execution and experience of training junior members.
- Publication and external presentation track records demonstrating strong technical innovation capabilities and industrial influence.
- People management experience is strongly desired.
- Experience working with contract development and manufacturing organization is highly preferred.
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans.
- Discretionary annual bonus.
- Discretionary stock-based long-term incentives.
- Paid time off.
