Senior Research Scientist
Viatris
11 hours ago
On-site
San Antonio, TX
Clinical Research and Development
Senior Research Scientist
Key responsibilities:
- Make laboratory batches for early product development; conduct procedures per established protocols, DEA, cGMP, and regulatory guidelines; maintain clean and safe environment.
- Plan, design, execute, and complete projects; provide creative, thorough solutions.
- Contribute new ideas; present research results; perform literature searches/evaluations; comply with lab/safety procedures and regulatory requirements; provide technical expertise and guidance as formulation/process SME.
- Write manufacturing process instructions per cGMP; support manufacturing at the Plant from R&D through Process Validation.
- Write/review/edit technical documents (SOPs, SMAs, TRs).
- Apply current technology; evaluate investigations and literature.
- Present and lead projects with considerable research; identify intellectual-property-distinguishable work.
- Coordinate with internal/external departments to progress projects.
- Support site quality activities (product investigations, change controls, CAPAs) in a timely manner.
- MS Office proficiency; train others on scientific software; evaluate/recommend acquisition of hardware/software.
- Mentor and develop direct reports; supervise formulation development and scale-up timelines.
- Review/approve project protocols and ensure labor estimates support scope.
- Review/approve compounding modules and process instructions for plant batch manufacturing.
- Author regulatory submission documents.
- Comply with safety, environmental, and quality practices per guidelines/SOPs and applicable regulations; perform other duties as assigned.
Minimum qualifications:
- Ph.D.: 4–6 years; Master’s: 7–9 years; Bachelor’s: 10–12 years related experience. Pharmaceutical product/process development experience required.
- Knowledge of semi-solid dosage form and/or new drug delivery system development.
- Strong knowledge of regulatory requirements and cGMPs.
- Ability to organize/prioritize work; develop research protocols; analyze and interpret data.
- Strong computer, report writing, lab, analytical, and organizational skills.
- Excellent communication; ability to work with diverse teams and manage multiple projects under aggressive timelines.
- Strong technical leadership and organizational/communication skills.
- Ability to coordinate/prioritize multiple projects in a fast-paced environment.
Key responsibilities:
- Make laboratory batches for early product development; conduct procedures per established protocols, DEA, cGMP, and regulatory guidelines; maintain clean and safe environment.
- Plan, design, execute, and complete projects; provide creative, thorough solutions.
- Contribute new ideas; present research results; perform literature searches/evaluations; comply with lab/safety procedures and regulatory requirements; provide technical expertise and guidance as formulation/process SME.
- Write manufacturing process instructions per cGMP; support manufacturing at the Plant from R&D through Process Validation.
- Write/review/edit technical documents (SOPs, SMAs, TRs).
- Apply current technology; evaluate investigations and literature.
- Present and lead projects with considerable research; identify intellectual-property-distinguishable work.
- Coordinate with internal/external departments to progress projects.
- Support site quality activities (product investigations, change controls, CAPAs) in a timely manner.
- MS Office proficiency; train others on scientific software; evaluate/recommend acquisition of hardware/software.
- Mentor and develop direct reports; supervise formulation development and scale-up timelines.
- Review/approve project protocols and ensure labor estimates support scope.
- Review/approve compounding modules and process instructions for plant batch manufacturing.
- Author regulatory submission documents.
- Comply with safety, environmental, and quality practices per guidelines/SOPs and applicable regulations; perform other duties as assigned.
Minimum qualifications:
- Ph.D.: 4–6 years; Master’s: 7–9 years; Bachelor’s: 10–12 years related experience. Pharmaceutical product/process development experience required.
- Knowledge of semi-solid dosage form and/or new drug delivery system development.
- Strong knowledge of regulatory requirements and cGMPs.
- Ability to organize/prioritize work; develop research protocols; analyze and interpret data.
- Strong computer, report writing, lab, analytical, and organizational skills.
- Excellent communication; ability to work with diverse teams and manage multiple projects under aggressive timelines.
- Strong technical leadership and organizational/communication skills.
- Ability to coordinate/prioritize multiple projects in a fast-paced environment.