Job description
NovaChem Labs, a leading innovator in analytical chemistry for pharmaceutical and specialty chemical markets, is seeking a Senior Analytical Chemist to join our Process Development team in Boston. This role focuses on advancing analytical methods from early development through scale‑up, ensuring robust, regulatorily compliant data to support product timelines.
We offer a collaborative, fast-paced environment with access to state-of-the-art instrumentation and opportunities to influence product development at a high level.
Responsibility
- Lead development and validation of analytical methods (HPLC/UPLC, GC/GC-MS, LC-MS/MS, NMR, FTIR) for drug substances and finished products.
- Plan and execute method transfers to QC and manufacturing, ensuring compliance with GMP and GLP requirements.
- Design experiments to support process development and scale‑up, including design of experiments (DoE) and statistical analysis.
- Troubleshoot analytical instrumentation, maintain calibration and preventive maintenance schedules.
- Prepare technical reports, SOPs, and documentation for regulatory submissions and audits.
- Collaborate with Manufacturing, QA, Regulatory Affairs, and Equipment teams to resolve quality issues and improve robustness.
- Mentor junior chemists and contribute to a culture of scientific rigor and continuous improvement.
Qualification
- MS or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or a closely related field.
- 5+ years of hands-on experience in analytical method development, validation, and transfer in pharmaceutical or chemical industries.
- Proficiency with HPLC/UPLC, GC/GC-MS, LC-MS/MS, NMR, and other analytical techniques; strong data analysis skills (Empower, ChemStation, MassLynx).
- In-depth knowledge of GMP/GLP, QA documentation, deviation investigations, and regulatory expectations (ICH Q2, ICH Q3, stability studies).
- Excellent problem-solving, communication, and cross-functional collaboration abilities.
- Experience with method validation, troubleshooting, and instrument maintenance management.
- Strong record of publication or presentation of analytical work is a plus.