Lead Formulation Scientist

Key responsibilities

• Provide technical support of tech transfer activities for existing products.
• Review proposals/timelines, protocols, manufacturing documents, test results and reports for tech transfer projects.
• Track project progress and provide timely updates to key stakeholders.
• Manufacture experimental batches in support of tech transfer activities and provide support during the manufacture of tech transfer qualification batches.
• Troubleshoot any problems that occur during tech transfer activities.
• Prepare and review technical regulatory documents in support of tech transfer submissions.
• Design formulations and processes for new products and manufacture development, optimization and scale-up batches for new products.

Requirements

• A minimum of a Bachelor's degree (or equivalent) and 9 years of experience, a Master’s degree with 7 years of experience or a doctorate with 5 years’ experience preferably in the pharmaceutical industry or related scientific field is preferred.
• Experience with generic drug development desirable.
• Demonstrates comprehensive understanding of solid oral dosage form development, process optimization and scale-up.
• Must understand the pharmacokinetics of drugs.
• Must have working knowledge of cGMPs, Standard Operating Procedures, FDA regulations and safety.
• Possesses strong writing, communication, comprehension, interpretation, problem solving, team, critical thinking, and organization skills.
• Possesses the ability to use creativity to solve formulation problems and make sound decisions in manufacturing situations.
• Possesses excellent technical computer skills including MS Office Suite.
• May be required to stand; walk; stoop; bend; kneel; and climb steps.
• May require use of hands and use of arms to lift and scoop.
• May be required to lift or maneuver boxes or containers using lifting equipment, as well as physically push, roll or lift.
• May be required to wear personal protective equipment including but not limited to: respiratory protection, safety glasses, hearing protection, safety shoes and protective clothing.
• Light to medium lifting requirements.
• Travel is required as needed.

Qualifications

• Pharmaceutics, Chemical Engineering, Chemistry or related scientific fields are preferred.
• Advanced mathematical skills preferred.
• Familiarity using formulas in Microsoft Excel preferred.
• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
• Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.