Scientist II, Analytical Development
On-siteBedford, Massachusetts, United States
Job Summary
Conduct method development, validation, and routine testing activities using techniques such as HPLC, UV, GC, cascade impaction, and dissolution to support formulation development, stability studies, and clinical material release. Execute defined experiments under senior guidance, analyze results to identify trends, and draft technical reports while maintaining GLP/GMP compliance and audit readiness. Participate in cross-functional discussions with Formulation, Process Development, and Quality teams to contribute analytical perspectives and troubleshoot instrumentation issues. Identify workflow improvements and propose practical solutions to enhance analytical robustness.
Required Qualifications
- M.S. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 1–3 years of experience
- B.S. with 2–4 years of relevant experience
- Hands-on experience with analytical instrumentation and data analysis
- Familiarity with ICH guidelines, GMP/GLP, and laboratory documentation practices
- Strong attention to detail
- Organizational skills
- A demonstrated ability to apply learning to new technical challenges
Desired Qualifications
- Experience supporting clinical-stage pharmaceutical development
- Exposure to method validation and regulatory documentation
- Familiarity with electronic lab notebooks or LIMS systems
- Experience working in a regulated environment or with CROs/CDMOs
- Experience working with small molecules
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