Overview In this role you will support analytical method development, validation, transfer, and sample testing to enable process chemistry and manufacturing. You will work within a cross-functional team to troubleshoot moderate complexity analytical challenges and contribute as a project leader on client work. The position emphasizes applying analytical tools, maintaining GMP/cGLP practices, and owning equipment and data integrity. This is a hands-on science role at a global CRO/CDMO with opportunities to influence projects across multiple therapeutic modalities.
Compensation / Benefits- Comprehensive Medical, Dental & Vision Insurance
- 401(k) with employer matching
- Generous PTO and holidays
- HSA contributions and FSA options
- Life Insurance and disability coverage
- Professional development opportunities
Responsibilities- Demonstrate core analytical laboratory expertise and support process development and scale-up.
- Apply a broad range of analytical tools and techniques to projects.
- Design and execute core experiments, interpret results, and plan follow-up work.
- Review data, notebooks, and instrument qualification reports.
- Serve as an analytical project lead on client projects; report results, trend data, and present at meetings; delegate work as needed.
- Possibly supervise one or more junior staff and oversee their progress.
- Own equipment/instrument systems, support qualification activities, and participate in software validation.
- Support audits, enforce GMP/cGLP compliance, and maintain safety protocols.
- Write, revise, and evaluate SOPs.
Key requirements- PhD in Chemistry or related field with no industry experience (as stated)
- MS with 3+ years or BS with 5 years in pharmaceutical industry
- Experience applying analytical skills to method design, development, and implementation
- Troubleshooter of technical problems
- 3 years of experience with HPLC, GC, FTIR, UV, Mass Spectrometry
- Ability to contribute to multi-disciplinary teams
- Knowledge of cGLP/cGMP and FDA/EMA/ICH guidance
- Ability to supervise staff
- Expert use of core laboratory techniques to impact APIs and intermediates
- effective collaboration in multidisciplinary teams
- leadership and supervision capability
- strong communication and data presentation skills
- HPLC
- GC
- FTIR