Summary:
The Scientist II in Analytical Development is an early-career scientific contributor who supports method development, validation, and routine testing for clinical programs, operating with moderate independence and collaborating with senior and cross-functional partners to ensure compliant, high-quality data.
Key Responsibilities:
- Analytical Method Development: Design and execute defined experiments under senior guidance; apply HPLC, UV, GC, cascade impaction, and dissolution.
- Method Execution and Data Analysis: Perform routine/non-routine testing for formulation development, stability studies, and clinical material release; analyze/interprete results and present findings.
- Documentation: Draft/maintain lab notebooks, technical reports, and method development summaries per internal SOPs and regulatory expectations.
- Compliance & Quality: Conduct work in accordance with GLP/GMP; maintain accurate records and support audit readiness.
- Troubleshooting: Participate in troubleshooting analytical methods/instrumentation.
- Cross-Functional Collaboration: Contribute analytical perspectives with Formulation, Process Development, and Quality.
- Continuous Learning: Stay current with analytical techniques and regulatory expectations; attend training.
- Process Improvement: Propose practical improvements to workflows/documentation/analytical robustness.
- Team Contribution: Support shared lab responsibilities and group discussions.
Required Qualifications:
- M.S. (Analytical Chemistry/Biochemistry/Pharmaceutical Sciences or related) with 1β3 years, or B.S. with 2β4 years relevant experience.
- Hands-on analytical instrumentation and data analysis experience.
- Familiarity with ICH, GMP/GLP, and lab documentation practices.
- Strong attention to detail and organizational skills.
Preferred Qualifications:
- Experience supporting clinical-stage pharmaceutical development.
- Exposure to method validation and regulatory documentation.
- Familiarity with electronic lab notebooks or LIMS.
- Regulated environment experience or with CROs/CDMOs.
- Experience with small molecules.