Principal Scientist, Process Development

Responsibilities

• Develop chemical processes for the manufacturing of drug substances, including route selection and step optimization.
• Plan, execute, and analyze laboratory experimentation to advance knowledge of production and quality attributes.
• Collaborate with senior scientists to develop project strategies for manufacturing to support clinical studies and commercialization.
• Manage day-to-day project team members and research assignments, including the design and interpretation of experiments.
• Prepare and review technical documents such as research reports, process development reports, and Master Batch Records (MBRs).
• Provide technical support for manufacturing processes performed under cGMP in both laboratory and large-scale operations.
• Collaborate across functional areas including analytical chemistry, quality assurance, and manufacturing.

Requirements

• PhD in Organic Chemistry (or related discipline) with 5+ years of relevant experience, OR MSc with 8+ years of experience, OR BSc with 10+ years of experience.
• Proven experience in planning and executing multi-step synthesis of organic molecules.
• Experience scaling up synthetic routes and developing safe chemical processes.
• Proficiency with purification and analytical techniques, including HPLC, LCMS, and NMR.
• Strong critical thinking, problem-solving, and organizational skills.
• Excellent verbal and written communication skills for cross-functional collaboration.

Preferred Qualifications

• Experience with pilot plant or large-scale plant operations.
• Experience generating master batch records.
• Familiarity with process validation, regulatory filings, and cGMP regulatory guidelines.
• Previous experience in project or people management.

About the Company

Gilead is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that improve lives and ensure global access to life-changing scientific innovations.