Formulation Scientist

Viatris•Morgantown, WV

20h

About The Position

The Formulation Scientist designs formulations and processes for new products and manufactures development, optimization, and scale-up batches. The role evaluates product testing results, finalizes production formulations and processes, and troubleshoots issues arising during scale-up or production. It also supports technology transfers for existing products and prepares technical reports and regulatory documents for new product submissions. The scientist reports project status, including development plans and timelines, to a supervisor; stays current with applicable federal guidelines, compendial requirements, technical innovations, and project-related topics; and attends training to maintain and improve cGMP and safety knowledge. Other duties may be assigned. The work spans laboratory, pilot and production plant, light manufacturing, and office environments, working independently or closely with others. Travel may be required as needed.

Requirements

Minimum of a bachelor's degree or equivalent and 2–4 years of experience.
Demonstrated comprehensive understanding of solid oral dosage form development, process optimization, and scale-up.
Understanding of basic pharmacokinetic principles of drugs.
Working knowledge of cGMPs, Standard Operating Procedures, FDA regulations, and safety.
Strong writing, communication, comprehension, interpretation, problem-solving, teamwork, critical-thinking, and organizational skills.
Ability to use creativity to solve formulation problems and make sound decisions in manufacturing situations.
Excellent technical computer skills, including Microsoft Office Suite.
Ability to read and interpret complex business or technical documents and write comprehensive reports and detailed business correspondence.
Ability to work with managers or directors and communicate ambiguous concepts, and to present to groups across the organization.
Ability to perform arithmetic and statistical computations.
Ability to solve problems involving concrete variables through semi-standardized solutions requiring ingenuity and analysis, and to draw inferences and follow detailed procedures to solve moderately complex problems.
May need to stand, walk, stoop, bend, kneel, climb steps, use hands and arms to lift or scoop, and push, roll, lift, or maneuver boxes or containers using lifting equipment.
May need to wear personal protective equipment, including respiratory protection, safety glasses, hearing protection, safety shoes, and protective clothing. Light-to-medium lifting may be required.
Travel as needed.

Nice To Haves

A bachelor's degree and 5 years of experience, a master's degree with 2 years of experience, or a doctorate with 0–2 years of experience, preferably in the pharmaceutical industry or a related scientific field.
Degree in Pharmaceutics, Chemical Engineering, Chemistry, or a related scientific field.
Experience with generic drug development.
Advanced mathematical skills.
Familiarity with formulas in Microsoft Excel.
A combination of experience and education may be considered.

Responsibilities

Design formulations and processes for new products.
Manufacture development, optimization, and scale-up batches for new products.
Evaluate product testing results and finalize production formulations and processes.
Troubleshoot problems during scale-up or production.
Write technology transfer reports, development reports, and other technical regulatory documents for new product submissions.
Provide technical support for technology transfer activities for existing products.
Report project status, development plans, and timelines to a supervisor.
Keep current with federal guidelines, compendial requirements, technical innovations, and topics of current interest relating to projects.
Attend training to maintain and increase skills and knowledge of cGMPs and safety awareness.
Perform other duties as assigned.