Senior Research Associate, FPD

Gilead Sciences•Foster City, CA

About The Position

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. A Sr. Research Associate 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.

Requirements

2+ years of experience with BS degree in related scientific discipline.
OR 0+ years of experience with MS degree in related scientific discipline.

Responsibilities

Files and retrieves project-related records.
Maintains the proper functions of laboratories.
Operates laboratory instrumentation and/or processing equipment and can train others to conduct simple experiments.
Executes and may begin designing low complexity experiments in support of cross-functional projects.
Troubleshoots basic analytical methods and instrument operation.
Performs drug substance, drug product intermediate and drug product characterization.
May support manufacturing of development batches for drug product.
Works collaboratively with peers from other departments.
May assist in training less experienced colleagues on techniques required for their duties, while ensuring that quality, safety and environmental standards are maintained.
Summarizes experimental results and presents at team meetings and department presentations.
Authors templated memos and reports with limited guidance.
Follows Environmental, Health and Safety (EHS) Policies and FPD-specific.
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.
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.