Lead Scientist
Viatris
July 01, 2026
On-site
Morgantown, WV
Clinical Research and Development
Key Responsibilities:
- Develop and validate quantitative and/or immunogenicity assays compliant with applicable regulatory guidance.
- Design, perform, and evaluate method development and validation experiments for quantitative and/or immunogenicity assays.
- Manage scientists and other laboratory personnel conducting method development and validation experiments (as assigned).
- Evaluate, summarize, and present analytical results and progress to Bioanalytical Laboratory management and clinical program teams.
- Serve as a bioanalytical subject matter expert (SME) to clinical operations program teams.
- Document laboratory activity per established procedures.
- Write, review, and approve Bioanalytical Laboratory reports.
- Troubleshoot analytical problems during study sample analysis.
- Serve as a scientific/technical resource for junior laboratory staff.
- Review data and documentation for scientific soundness and compliance with SOPs and regulatory guidelines.
- Write, review, and approve analytical methods and SOPs.
Qualifications:
- Bachelor’s degree (or equivalent) and 7–10 years’ experience; Doctorate with 6 years, Master’s with 8 years, or Bachelor’s with 10 years preferred (combination of education/experience considered).
- Knowledge of quantitative bioanalysis and/or immunogenicity testing techniques and instrumentation (e.g., HPLC, mass spectrometry, ligand binding assays, automation, sample prep). Familiar with GLP.
- Strong oral/written communication and analytical skills; working knowledge of Microsoft Word/Excel and instrument control/data acquisition software.
- Ability to supervise employees and plan/assign/direct work.
- Ability to read/interpret complex technical/business documents; write comprehensive reports; present to multidisciplinary groups.
- Mathematical problem-solving and complex computations.
- Ability to follow procedures and solve moderately complex problems.
- Normal laboratory environment; routine exposure to chemicals/solvents/fumes and handling human biological samples.
- English proficiency required.
- Develop and validate quantitative and/or immunogenicity assays compliant with applicable regulatory guidance.
- Design, perform, and evaluate method development and validation experiments for quantitative and/or immunogenicity assays.
- Manage scientists and other laboratory personnel conducting method development and validation experiments (as assigned).
- Evaluate, summarize, and present analytical results and progress to Bioanalytical Laboratory management and clinical program teams.
- Serve as a bioanalytical subject matter expert (SME) to clinical operations program teams.
- Document laboratory activity per established procedures.
- Write, review, and approve Bioanalytical Laboratory reports.
- Troubleshoot analytical problems during study sample analysis.
- Serve as a scientific/technical resource for junior laboratory staff.
- Review data and documentation for scientific soundness and compliance with SOPs and regulatory guidelines.
- Write, review, and approve analytical methods and SOPs.
Qualifications:
- Bachelor’s degree (or equivalent) and 7–10 years’ experience; Doctorate with 6 years, Master’s with 8 years, or Bachelor’s with 10 years preferred (combination of education/experience considered).
- Knowledge of quantitative bioanalysis and/or immunogenicity testing techniques and instrumentation (e.g., HPLC, mass spectrometry, ligand binding assays, automation, sample prep). Familiar with GLP.
- Strong oral/written communication and analytical skills; working knowledge of Microsoft Word/Excel and instrument control/data acquisition software.
- Ability to supervise employees and plan/assign/direct work.
- Ability to read/interpret complex technical/business documents; write comprehensive reports; present to multidisciplinary groups.
- Mathematical problem-solving and complex computations.
- Ability to follow procedures and solve moderately complex problems.
- Normal laboratory environment; routine exposure to chemicals/solvents/fumes and handling human biological samples.
- English proficiency required.