Lead Formulation Scientist
Viatris
4 hours ago
On-site
Morgantown, WV
Operations
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 progress and provide timely updates to key stakeholders.
- Manufacture experimental batches in support of tech transfer activities; support tech transfer qualification batch manufacturing; troubleshoot issues.
- Prepare and review technical regulatory documents in support of tech transfer submissions.
- Design formulations and processes for new products; manufacture development, optimization and scale-up batches for new products.
- Keep current with Federal guidelines, compendial requirements, technical innovations, and topics of current interest pertaining to projects.
- Attend training sessions to maintain/increase skills and knowledge of cGMPs and safety awareness.
Minimum qualifications:
- Bachelor’s degree (or equivalent) plus 9 years of experience; Master’s (7 years) or Doctorate (5 years) preferred in pharmaceutical industry or related scientific field. Degrees in Pharmaceutics, Chemical Engineering, Chemistry or related fields preferred. Generic drug development experience desirable.
- Comprehensive understanding of solid oral dosage form development, process optimization and scale-up; understand pharmacokinetics; working knowledge of cGMPs, SOPs, FDA regulations, and safety.
- Strong writing, communication, comprehension, interpretation, problem solving, teamwork, critical thinking, and organization skills; creativity to solve formulation problems and make sound manufacturing decisions; excellent technical computer skills (MS Office Suite).
- Ability to read/interpret complex technical documents; write comprehensive reports and correspondence; work with managers/directors and communicate ambiguous concepts; present across the organization.
- Ability to perform statistical computations; advanced math preferred; familiarity with Excel formulas preferred.
- Ability to solve moderately complex problems using semi-standardized solutions and follow prescribed procedures.
Additional requirements:
- Physical requirements: may stand/walk/stoop/bend/kneel/climb; may lift/maneuver boxes/containers; may require PPE (e.g., respiratory protection, safety glasses, hearing protection, safety shoes, protective clothing); light to medium lifting; travel as needed.
- Work environment: laboratory, pilot/production plant, and office; working alone or with others.
- 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 progress and provide timely updates to key stakeholders.
- Manufacture experimental batches in support of tech transfer activities; support tech transfer qualification batch manufacturing; troubleshoot issues.
- Prepare and review technical regulatory documents in support of tech transfer submissions.
- Design formulations and processes for new products; manufacture development, optimization and scale-up batches for new products.
- Keep current with Federal guidelines, compendial requirements, technical innovations, and topics of current interest pertaining to projects.
- Attend training sessions to maintain/increase skills and knowledge of cGMPs and safety awareness.
Minimum qualifications:
- Bachelor’s degree (or equivalent) plus 9 years of experience; Master’s (7 years) or Doctorate (5 years) preferred in pharmaceutical industry or related scientific field. Degrees in Pharmaceutics, Chemical Engineering, Chemistry or related fields preferred. Generic drug development experience desirable.
- Comprehensive understanding of solid oral dosage form development, process optimization and scale-up; understand pharmacokinetics; working knowledge of cGMPs, SOPs, FDA regulations, and safety.
- Strong writing, communication, comprehension, interpretation, problem solving, teamwork, critical thinking, and organization skills; creativity to solve formulation problems and make sound manufacturing decisions; excellent technical computer skills (MS Office Suite).
- Ability to read/interpret complex technical documents; write comprehensive reports and correspondence; work with managers/directors and communicate ambiguous concepts; present across the organization.
- Ability to perform statistical computations; advanced math preferred; familiarity with Excel formulas preferred.
- Ability to solve moderately complex problems using semi-standardized solutions and follow prescribed procedures.
Additional requirements:
- Physical requirements: may stand/walk/stoop/bend/kneel/climb; may lift/maneuver boxes/containers; may require PPE (e.g., respiratory protection, safety glasses, hearing protection, safety shoes, protective clothing); light to medium lifting; travel as needed.
- Work environment: laboratory, pilot/production plant, and office; working alone or with others.