Senior Scientist, Analytical Chemistry

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

Essential Functions:

• Develop and validate analytical methods (mostly LC and GC) for APIs, excipients, and dosage forms for routine analysis; optimize and qualify new/existing methods.
• 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 state/federal regulations.
• Use and calibrate analytical instruments (e.g., sonic sifter, laser diffraction, Karl Fischer, UV-Vis, FTIR, HPLC with UV/conductivity, TLC, pH meter, dissolution apparatus) and related equipment.
• Provide timely responses to internal/external inquiries.
• Train and guide analysts; expand analytical capabilities.
• Execute and document analyses; calculate/report results; investigate and review data for completeness and specification compliance.
• Evaluate, recommend, and implement new analytical technologies and instrumentation.

Additional Responsibilities:

• Stay current on analytical technology developments; improve lab efficiency and GMP compliance.
• Lead team members on assigned projects.
• Participate/lead scientific discussions with cross-functional teams.

Qualifications:

• Education: BS/BA in chemistry or relevant pharmaceutical sciences (Required); MS/MA (Preferred).
• Experience: 5+ years pharmaceutical experience with BS/BA; 4+ years with MS/MA.
• Specialized Knowledge/Skills: In-depth analytical chemistry (spectrophotometric, dissolution/drug release, chromatographic, physical parameter measurements), ability to follow USP/EP/BP/JP procedures and apply cGMP; advanced troubleshooting; trend identification in analytical data; hands‑on HPLC, GC, dissolution, UV, FTIR, TLC, MS; method development/validation; experience writing SOPs and test methods; regulatory document compilation experience.

Compensation/Benefits:

• Base salary range: $90,000–$123,000/year; short-term incentive/bonus opportunity within first 12 months. Benefits include health/insurance and 401(k) match (for eligible positions).