
Scientist II, Analytical Development
- Danbury, CT
- $70,400-105,600 per year
- Permanent
- Full-time
- Analytical Method Support: Assist in the development and optimization of analytical methods using techniques such as HPLC, UV, GC, and cascade impaction.
- Method Execution & Data Analysis: Perform routine and non-routine testing to support formulation development, stability studies, and clinical material release.
- Documentation: Draft and maintain laboratory notebooks, technical reports, and method development summaries in compliance with internal SOPs and regulatory expectations.
- Compliance & Quality: Ensure all work is conducted in accordance with appropriate standards. Maintain accurate records and support audit readiness.
- Troubleshooting: Participate in troubleshooting analytical methods and instrumentation issues under the guidance of senior staff.
- Cross-Functional Collaboration: Work with Formulation, Process Development, and Quality teams to support program needs and timelines.
- Continuous Learning: Stay current with analytical techniques and regulatory expectations. Participate in training and development opportunities.
- Process Improvement: Identify and suggest improvements to laboratory workflows, documentation practices, or analytical robustness.
- Team Contribution: Support team goals by contributing to shared lab responsibilities and participating in group meetings and discussions.
- Other Duties: Perform additional tasks as assigned to support the Analytical Development function.
- M.S. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 1+ years of experience, or B.S. with 2+ years of 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, and willingness to learn.
- Experience supporting clinical-stage pharmaceutical development.
- Exposure to method validation and regulatory documentation.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
- Familiarity with inhalation drug delivery systems and aerosol testing is a plus.