Small Molecule Formulation and Process Development (FPD) provides formulation, process, and manufacturing support and technical expertise throughout research and development, from pre-exploratory to commercialization.
Job Responsibilities:
- Organizes, files and retrieves project-related records.
- Maintains the proper functions of laboratories.
Technical:
- Operates laboratory instrumentation and/or processing equipment; trains others to conduct moderate to high complexity experiments (may be a subject matter expert on one or more pieces of equipment).
- Designs and executes experiments for 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 product batches.
- Develops and optimizes manufacturing processes.
- Works collaboratively with peers and external partners.
- Trains less experienced colleagues while ensuring quality, safety, and environmental standards.
- Assists in preparation and review of GMP documentation.
- Summarizes experimental results and presents conclusions in meetings and presentations.
- Authors reports and contributes to regulatory submissions (IND, IMPD, NDA, etc.).
Safety & Compliance:
- Follows EHS policies and FPD-specific safety protocols.
- Maintains workplace compliance with no violations/major observations during inspections.
- Completes required safety and GMP training by due date.
- Ensures SOPs are followed and required information is recorded properly.
- Accurately documents results in electronic lab notebook.
General:
- Applies Gilead Core Values and Leadership Commitments.
- Demonstrates verbal communication and interpersonal skills.
- Works collaboratively on communication and problem-solving.
- Acts as a resource within the department.
Basic Qualifications:
- 6+ years with BS OR 4+ years with MS OR 0+ years with PhD.
Preferred & Experience Requirements:
- 11+ years with BS (related scientific discipline) OR 9+ years with MS (related scientific discipline) OR 0+ years with PhD (related scientific discipline).
- Works independently; determines methods/techniques on new or difficult assignments.
- May design new experiments for drug substance/drug product development.
- Works on complex problems requiring comprehensive evaluation.
- Maintains expertise via scientific literature and applies appropriately to projects.