Associate Scientist, FPD

Job Description

Small Molecule Formulation and Process Development (FPD) provide formulation, process, and manufacturing support and technical expertise throughout research and development, from pre-exploratory to commercialization. An Associate Scientist within FPD may support teams conducting compounding screening to enable drug candidate selection, drug substance physio/chemical property assessment and form selection, development of clinical formulations and manufacturing processes, small molecule drug product manufacturing tech transfer and scale-up at internal and external sites, oversight of small molecule drug product manufacturing, and establishment a robust DP formulation and optimized manufacturing process to enable commercial production. FPD formulation scientists develop the small molecule formulation and manufacturing process control strategies and authors technical reports, risk assessments, and regulatory filings from IND to NDA. FPD supports DP manufacturing process validation and provides technical expertise throughout post-approval commercial manufacturing and life-cycle management.

Job Responsibilities:

Administrative:

• Organizes, files and retrieves project-related records.

• Maintains the proper functions of laboratories.

Technical:

• Operates laboratory instrumentation and/or processing equipment and can train others to conduct low to moderate complexity experiments.

• Designs and executes low to moderate complexity experiments in support of cross-functional projects.

• Troubleshoots analytical methods, instrument operation, manufacturing and experimental design.

• Performs drug substance, drug product intermediate and drug product characterization.

• May oversee routine GMP clinical manufacture of drug products and/or development batches.

• Works collaboratively with peers from other departments and external partners.

• Summarizes experimental results and presents conclusions in team meetings and department presentations.

• Authors templated memos and reports. Authors medium complexity.

Safety & Compliance:

• Follows Environmental, Health and Safety (EHS) Policies and FPD-specific safety protocols.

• Maintains workplace compliance to achieve no violations or major observations during EHS or regulatory agency inspections.

• Completes all required safety and GMP training by the required due date.

• Ensures that standard operating procedures (SOPs) are followed as written, and required information is recorded properly.

• Accurately documents results in electronic lab notebook.

General:

• Applies Gilead Core Values and Leadership Commitments to job responsibilities.

• Demonstrates good verbal communication and interpersonal skills.

• Works with a collaborative communication and problem-solving spirit.

Education & Experience Requirements:

• 5+ years of experience with BS degree in related scientific discipline.

OR

• 3+ years of experience with MS degree in related scientific discipline.