Senior Lead Scientist
Viatris
4 hours ago
Remote friendly (Morgantown, WV)
United States
Clinical Research and Development
Key Responsibilities:
- Overall assessments of alternate API suppliers for commercial products with the R&D API sourcing team and related groups to support commercial manufacture.
- Discuss and/or perform analytical testing on API sourcing samples using methods including NMR, HPLC, LC-MS/MS, GC, DSC, TGA, CD, UV, and IR spectroscopy.
- Critically evaluate and audit data.
- Write API sourcing reports for alternative supplier source selection.
- Interface with CMOs and cross-functional teams to define analytical method transfer strategy and provide routine project updates.
- Lead and coordinate end-to-end analytical method transfers across external sites.
- Develop and support analytical method transfer and execution (method transfer materials, AMT protocol, reports, and auditing AMT results across donor and recipient sites).
- Lead and participate in scientific investigations and troubleshoot issues during analytical transfer or scale-up.
- Work with Human Relations on interviewing, employee appraisals, disciplinary actions, and resolving employee issues.
- Serve as department representative internally and externally to third-party labs, manufacturers, and/or regulatory agencies.
- Act as a scientific resource for the company.
Minimum Qualifications:
- Bachelor’s degree (or equivalent) and 6–10 years of experience; Master’s (or equivalent) and 4 years, or Doctorate (or equivalent) preferred (combination of education/experience considered).
- Knowledge of analytical methods common to the pharmaceutical industry, industry practices, and health authority regulations/guidances.
- Strong analytical chemistry background.
- SME for Analytical Method Validation and transfer.
- Maintain meticulous experimental records ensuring data integrity and compliance with EH&S and regulatory standards; strong communication/reading skills; basic Microsoft Office knowledge; ability to operate chromatography data acquisition systems; multitasking across multiple projects.
- Ability to work effectively in a cross-functional team environment.
- Process experience in drug substances and drug products.
- Ability to read/interpret complex technical documents; write comprehensive reports and correspondence; communicate and present to groups.
- Ability to perform complex computations and solve moderately complex problems.
- Normal office and chemical laboratory situation; some physical activity (e.g., bending/kneeling/climbing steps).
- Overall assessments of alternate API suppliers for commercial products with the R&D API sourcing team and related groups to support commercial manufacture.
- Discuss and/or perform analytical testing on API sourcing samples using methods including NMR, HPLC, LC-MS/MS, GC, DSC, TGA, CD, UV, and IR spectroscopy.
- Critically evaluate and audit data.
- Write API sourcing reports for alternative supplier source selection.
- Interface with CMOs and cross-functional teams to define analytical method transfer strategy and provide routine project updates.
- Lead and coordinate end-to-end analytical method transfers across external sites.
- Develop and support analytical method transfer and execution (method transfer materials, AMT protocol, reports, and auditing AMT results across donor and recipient sites).
- Lead and participate in scientific investigations and troubleshoot issues during analytical transfer or scale-up.
- Work with Human Relations on interviewing, employee appraisals, disciplinary actions, and resolving employee issues.
- Serve as department representative internally and externally to third-party labs, manufacturers, and/or regulatory agencies.
- Act as a scientific resource for the company.
Minimum Qualifications:
- Bachelor’s degree (or equivalent) and 6–10 years of experience; Master’s (or equivalent) and 4 years, or Doctorate (or equivalent) preferred (combination of education/experience considered).
- Knowledge of analytical methods common to the pharmaceutical industry, industry practices, and health authority regulations/guidances.
- Strong analytical chemistry background.
- SME for Analytical Method Validation and transfer.
- Maintain meticulous experimental records ensuring data integrity and compliance with EH&S and regulatory standards; strong communication/reading skills; basic Microsoft Office knowledge; ability to operate chromatography data acquisition systems; multitasking across multiple projects.
- Ability to work effectively in a cross-functional team environment.
- Process experience in drug substances and drug products.
- Ability to read/interpret complex technical documents; write comprehensive reports and correspondence; communicate and present to groups.
- Ability to perform complex computations and solve moderately complex problems.
- Normal office and chemical laboratory situation; some physical activity (e.g., bending/kneeling/climbing steps).