Senior Scientist, Analytical Chemistry
Amneal Pharmaceuticals
19 days ago
On-site
Branchburg, NJ
Operations
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.
Essential Functions:
- 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, 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.
Additional Responsibilities:
- 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.
Qualifications:
- 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.
Compensation/Benefits:
- Base salary range: $90,000–$123,000/year. Short-term incentive/bonus/performance-based award available within first 12 months.
Benefits Program:
- Health/insurance benefits and 401(k) matching (for eligible positions).
Essential Functions:
- 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, 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.
Additional Responsibilities:
- 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.
Qualifications:
- 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.
Compensation/Benefits:
- Base salary range: $90,000–$123,000/year. Short-term incentive/bonus/performance-based award available within first 12 months.
Benefits Program:
- Health/insurance benefits and 401(k) matching (for eligible positions).