A fast-growing global biopharmaceutical company is seeking an analytical development scientist to join its Wilmington, Ohio-based team. Past supervisory experience is necessary for this position. The ideal candidate will have either an M.S. or a Ph.D.
This is an opportunity to drive the development of state-of-the-art analytical science and procedures supporting the solid oral dosage, sterile injectable, and protein therapeutics development programs within our global biopharmaceutical development portfolio from IND, to first in human, through full commercialization.
The primary responsibilities for the position include analytical method development and validation, analytical investigations, process and product characterization, design of stability studies, and specification setting for developmental and clinical drug product.
- Provide analytical and technical support to R&D and commercial operations.
- Identify and solve complex technical issues that correspond to atypical or out-of-specification/trend test results as well as instrumentation and methodology related.
- Willingness to learn new skills, assist on a wide variety of projects and be adaptable to new areas of development as priorities change within the department
- Provide technical leadership on interdepartmental initiatives through technical and CMC teams
- Generation and dissemination of scientific and technical data/documents which may be included in regulatory submissions
- Develop new chemical assays; write method qualification/validation protocols and reports.
- Write and disseminate technical data summaries and reports.
- Evaluate, develop, and apply new analytical technologies.
- Support the creation of CMC filings and other regulatory submissions.
- Interpret, analyze, and manage data.
- Troubleshoot technical problems.
- Write project proposals, and development reports.
- Perform experimental studies, investigations, and validations.
Education and Skills:
- D. in Chemistry, Biochemistry, Pharmacy, Biotechnology, or related field; prior pharmaceutical industry experience highly desirable and assignment flexibility to integrate project/program leadership responsibilities for highly experienced candidates. M.S./B.S. candidates will be considered with 10+ years’ experience and demonstrated track record in pharmaceutical method development assignments.
- Advanced skills in separation sciences (e.g., HPLC, UPLC, GC, SEC, IEC) with academic research and/or industry experience demonstrating successful application to solve chemistry problems.
- Team player and demonstrated collaboration in design and execution of experiments.
- Key skills include attention to details, creative/innovative thinker, adaptability, well organized, team player, and committed to quality in all work aspects.