Formulation Scientist

Viatris•Morgantown, WV

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 problems arising during scale-up or production. It prepares technical transfer and development reports and other technical regulatory documents for new product submissions, and provides technical support for technology transfer activities involving existing products. The position reports project status, including development plans and timelines, to a supervisor; stays current with relevant federal guidelines, compendial requirements, technical innovations, and project topics; and attends training to maintain and improve cGMP and safety knowledge. Other duties may be assigned. Work takes place in laboratory, pilot, production plant, light manufacturing, and office environments, either alone or closely with others. Travel is required as needed. Physical tasks may include standing, walking, stooping, bending, kneeling, climbing steps, using hands and arms to lift or scoop, and pushing, rolling, or lifting boxes or containers, sometimes with lifting equipment. Light to medium lifting may be required, and personal protective equipment may be worn.

Requirements

Minimum of a bachelor's degree or equivalent and 2–4 years of experience; the posting also gives preferred combinations of a bachelor's degree and 5 years of experience, a master's degree and 2 years of experience, or a doctorate and 0–2 years of experience.
Demonstrated comprehensive understanding of solid oral dosage form development, process optimization, and scale-up.
Understanding of basic drug pharmacokinetics principles.
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 the MS Office Suite.
Ability to read and interpret complex business or technical documents, write comprehensive reports and detailed business correspondence, communicate ambiguous concepts with managers or directors, and present to groups across the organization.
Ability to perform arithmetic and statistical computations.
Ability to solve problems with concrete variables using semi-standardized solutions requiring ingenuity and analysis, draw inferences, and follow detailed procedures to solve moderately complex problems.
Ability to perform physical tasks that may include standing, walking, stooping, bending, kneeling, climbing steps, lifting or scooping, and pushing, rolling, or lifting boxes or containers; light to medium lifting may be required.
Ability to wear personal protective equipment, including respiratory protection, safety glasses, hearing protection, safety shoes, and protective clothing, as needed.
Ability to travel as needed.

Nice To Haves

Experience 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 using formulas in Microsoft Excel.

Responsibilities

Design formulations and processes for new products and manufacture development, optimization, and scale-up batches.
Evaluate product testing results and finalize production formulations and processes.
Troubleshoot problems that occur during scale-ups or in 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, including development plans and timelines, to a supervisor.
Keep current with federal guidelines, compendial requirements, technical innovations, and topics of current interest related to projects.
Attend training sessions to maintain and increase cGMP and safety awareness and knowledge.
Perform other duties as assigned.