Sr Associate Scientist, FPD

Description de l'emploi

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. 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 moderate to high complexity experiments. May be a subject matter expert on one or more pieces of equipment.

• Designs and executes moderately complex 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 manufacture of GMP clinical and/or development drug products batches.

• Develops and optimizes manufacturing processes.

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

• Trains less experienced colleagues on techniques required for their duties, while ensuring that quality, safety and environmental standards are maintained.

• Assists in preparation and review of GMP documentation.

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

• Authors templated memos and reports. Authors medium complexity non-templated memos and reports with minimal guidance. May work with more experienced colleagues on low complexity sections for IND/IMPD and/or NDABLA submissions.

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.

• Acts as a resource for other colleagues within the department.

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.

Gilead Core Values

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)