Scientist, FPD

Job Description

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. A Scientist within FPD may support teams conducting compound 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 of a robust DP formulation and optimized manufacturing process to enable commercial production. FPD scientists develop the small molecule formulation and manufacturing process control strategies and author 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

• Organizes, 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 moderate to high complexity experiments; may be a subject matter expert on one or more pieces of equipment.
• Designs and executes 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 reports and contributes to regulatory submissions (IND, IMPD, NDA, etc.).
• 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.
• 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.

Basic Qualifications

• 6+ Years with BS
• 4+ Years with MS
• 0+ Years with PhD

Preferred & Experience Requirements

• 11+ years of experience with BS degree in related scientific discipline is highly preferred
• 9+ years of experience with MS degree in related scientific discipline is highly preferred
• 0+ years of experience with PhD in related scientific discipline is highly preferred
• Works independently and determines methods and techniques on new or difficult assignments.
• May design new experiments to support development of drug substances and drug products or techniques to test such substances.
• Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.
• Maintains high level of expertise through familiarity with scientific literature and applies appropriately to projects.