Lead Formulation Scientist

Lead Formulation Scientist page is loaded## Lead Formulation Scientist locations:
Morgantown, West Virginia, USAtime type:
Praca na pełny etatposted on:
Opublikowano dzisiajjob requisition :
R5666654

Mylan Pharmaceuticals Inc.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
* * Access* – Providing high quality trusted medicines regardless of geography or circumstance;
* * Leadership* – Advancing sustainable operations and innovative solutions to improve patient health; and
* * Partnership* – Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the Lead Formulation Scientist will make an impact:

Key responsibilities for this role include:
* 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.
* Keep current with all Federal guidelines, compendial requirements, technical innovations, and topics of current interest pertaining to projects.
* Attend training sessions in order to maintain and increase skills and knowledge of cGMP’s and safety awareness.

The minimum qualifications for this role are:
* 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.  Degrees in Pharmaceutics, Chemical Engineering, Chemistry or related scientific fields are preferred.  However, a combination of experience and/or education will be taken into consideration.

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.
* Must possess strong writing, communication, comprehension, interpretation, problem solving, team, critical thinking, and organization skills.  Must possess the ability to use creativity to solve formulation problems and make sound decisions in manufacturing situations.  Must possess excellent technical computer skills including MS Office Suite.
* Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.  Ability to work with managers or directors and communicate ambiguous concepts.  Ability to present to groups across the organization.
* Ability to add, subtract, multiply, divide and perform statistical computations.  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.
* 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 pushing, rolling or lifting.  May be required to wear personal protective equipment including but not limited to: respiratory…