POSITION SUMMARY:
AR&D Sr. Chemist is responsible for method development, validation, and analytical support activities for drug substances and drug products in a fast‑paced pharmaceutical environment. This role requires strong technical expertise in chromatographic and spectroscopic techniques, regulatory understanding, and the ability to guide junior scientists while collaborating cross‑functionally with Formulation, QC, Regulatory, and Manufacturing teams
MAJOR DUTIES/RESPONSIBILITIES:
- Method Development: Develop and optimize analytical methods (HPLC, UPLC, GC, Dissolution, UV, FTIR, KF, ICP, PSD, IVRT/IVPT etc.) for APIs and finished dosage forms.
- Method Validation: Perform and document method validation per ICH Q2(R2) guidelines.
- Stability Studies: Design and execute stability-indicating methods; support stability protocol creation and data review.
- Regulatory Documentation: Prepare analytical sections for regulatory submissions (ANDA, NDA, DMF).
- Instrument Troubleshooting: Maintain and troubleshoot analytical instruments; ensure calibration and qualification compliance.
- Data Review: Review and approve analytical data, notebooks, and reports under GMP/GLP expectations.
- Cross‑Functional Support: Provide analytical support to formulation development, scale‑up, and tech transfer.
- Team Leadership: Mentor junior chemists, train staff, and support workload planning.
- Perform other duties as assigned.
MINIMUM/PREFERRED REQUIREMENTS:
Education:
- Master’s / Ph.D. degree in chemistry, science or Pharmaceutics.
Experience:
- MS/Ph.D. with 5+ years of experience in a generic pharmaceutical analytical development lab.
- Must have good understanding of cGMPs and able to author quality investigations.
- Proficient in using Empower Chromatography software including custom field calculations.
PHYSICAL DEMANDS/ENVIRONMENTAL CONDITIONS:
- Laboratory and office environment.
- Able to lift about 25 pounds.
- Able to stand and or sit for longer period of time.
Job Type: Full-time
Pay: Up to $95,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Education:
Work Location: In person
