Lead Formulation Scientist
Viatris
19 days 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 for tech transfer activities; support manufacture of tech transfer qualification batches; troubleshoot problems.
- Prepare and review technical regulatory documents for tech transfer submissions.
- Design formulations and processes for new products; develop, optimize, and scale up batches.
- Stay current with Federal guidelines, compendial requirements, technical innovations, and relevant topics.
- Attend training to maintain/increase skills and knowledge of cGMPs and safety awareness.
Minimum Qualifications:
- Bachelor’s (or equivalent) + 9 years; or Master’s + 7 years; or Doctorate + 5 years, preferably in pharma or related scientific field. Pharmaceutics, Chemical Engineering, Chemistry, or related fields preferred. Generic drug development experience desirable.
- Solid oral dosage form development, process optimization, and scale-up; knowledge of pharmacokinetics. Working knowledge of cGMPs, SOPs, FDA regulations, and safety.
- Strong writing, communication, problem solving, teamwork, critical thinking, organization; creativity to solve formulation problems; excellent technical computer skills (MS Office).
- Ability to read/interpret complex business/technical documents; write comprehensive reports; communicate ambiguous concepts; present to groups.
- Ability to perform statistical computations; advanced math skills preferred; Excel formula familiarity preferred.
- Ability to solve moderately complex problems using prescribed/detailed procedures and analysis.
- Physical requirements may include standing/walking/bending/stooping/kneeling/climbing; lifting/maneuvering boxes/containers; PPE use; light to medium lifting; travel as needed.
- Laboratory, pilot/production plant, and office environments.
Benefits/Compensation/Application Instructions:
- Not specified in the provided text.
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 for tech transfer activities; support manufacture of tech transfer qualification batches; troubleshoot problems.
- Prepare and review technical regulatory documents for tech transfer submissions.
- Design formulations and processes for new products; develop, optimize, and scale up batches.
- Stay current with Federal guidelines, compendial requirements, technical innovations, and relevant topics.
- Attend training to maintain/increase skills and knowledge of cGMPs and safety awareness.
Minimum Qualifications:
- Bachelor’s (or equivalent) + 9 years; or Master’s + 7 years; or Doctorate + 5 years, preferably in pharma or related scientific field. Pharmaceutics, Chemical Engineering, Chemistry, or related fields preferred. Generic drug development experience desirable.
- Solid oral dosage form development, process optimization, and scale-up; knowledge of pharmacokinetics. Working knowledge of cGMPs, SOPs, FDA regulations, and safety.
- Strong writing, communication, problem solving, teamwork, critical thinking, organization; creativity to solve formulation problems; excellent technical computer skills (MS Office).
- Ability to read/interpret complex business/technical documents; write comprehensive reports; communicate ambiguous concepts; present to groups.
- Ability to perform statistical computations; advanced math skills preferred; Excel formula familiarity preferred.
- Ability to solve moderately complex problems using prescribed/detailed procedures and analysis.
- Physical requirements may include standing/walking/bending/stooping/kneeling/climbing; lifting/maneuvering boxes/containers; PPE use; light to medium lifting; travel as needed.
- Laboratory, pilot/production plant, and office environments.
Benefits/Compensation/Application Instructions:
- Not specified in the provided text.