Senior Scientist, Analytical Chemistry

The Senior Scientist, Analytical Chemistry supports analytical development and validation/verification, and method transfer for testing methods in the Quality Control laboratory to characterize drug substance, raw materials, and drug products.

• Develop and validate analytical methods (mostly LC and GC) for active pharmaceutical ingredients, excipients, and dosage forms for routine analysis; optimize and develop methods for qualification and release testing.
• Perform physical and chemical analysis of raw materials, in‑process, finished products, and stability samples per written methods, specifications, and SOPs; comply with cGMP and regulations to avoid out‑of‑specification.
• Use and calibrate instrumentation including sonic sifter, laser diffraction, Karl Fischer, UV‑Vis, FTIR, HPLC (UV and conductivity), TLC, pH meter, and dissolution equipment (auto‑sampler/inline UV), plus balances and Karl‑Fischer titrator.
• Respond to internal/external inquiries.
• Train and guide analysts; expand analytical capabilities.
• Ensure procedures meet standards of identity/strength/quality/purity; document steps, calculate/report results; investigate lab results; review data for completeness and specification compliance.
• Evaluate, recommend, and implement new analytical technologies and instrumentation.

• Stay abreast of analytical technology developments; improve efficiency and GMP compliance.
• Lead team members on assigned projects; participate/lead scientific discussions with cross‑functional teams.

• Education:
  
  BS/BA in chemistry or relevant pharmaceutical sciences (Required); MS/MA (Preferred).
• Experience:
  
  5+ years pharmaceutical experience with BS; 4+ years with MS.
• Specialized Knowledge/
  
  Skills:
  
  Analytical equipment/techniques (spectrophotometric, dissolution/drug release, chromatographic; physical measurements such as particle size/viscosity/DSC/TGA/XRPD); follow compendial methods (USP/EP/BP/JP); strong cGMP QC lab experience; troubleshoot complex analytical/instrument issues; identify analytical data trends; hands‑on HPLC, GC, dissolution, UV, FTIR, TLC, MS; method development and validation; experience writing SOPs/test methods; regulatory document compilation.

• Base salary range: $90,000–$123,000 per year. Short‑term incentive/bonus/performance‑based award available within the first 12 months.

• Health/insurance benefits and 401(k) matching (for eligible positions).