Scientist, Analytical Chemistry
Amneal Pharmaceuticals
9 hours ago
On-site
Branchburg, NJ
Operations
The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, and cleaning verification samples following written procedures and applicable SOPs. Calculates and reports results on applicable specification documents and participates in method transfer activities within departments or between facilities/organizations. Provides feedback on systems and analytical procedures to support continuous improvement and compliance.
Essential Functions:
- Perform chemical analysis of raw materials, in-process, and finished pharmaceutical products (including stability) using written/compendial methods, material specifications, and techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatography per SOPs.
- Prepare samples and perform complex chromatographic analyses; maintain laboratory records (notebooks/computer-based), document steps, and calculate/report results timely.
- Participate in method transfer activities between facilities/organizations.
- Investigate out-of-specification (OOS) laboratory results, as required.
- Perform physical analysis using X-ray diffraction, DSC, and Malvern mastersizer.
- Prepare/execute method transfer protocols and method verification/validation protocols.
Additional Responsibilities:
- Assist senior scientists as needed.
- Remove expired chemicals/reference standards; calibrate dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, and GC as assigned.
- Standardize API for use as in-house reference standard.
- Train newly hired technicians/Assistant Scientists on basic analytical techniques and instruments.
Qualifications:
- Required: BS/BA in Chemistry or related science discipline.
- Preferred: MS/MA in Chemistry or related science discipline.
- Experience: 3+ years (BS/BA) testing chemicals/pharmaceutical products; 1+ year (MS/MA) testing chemicals/pharmaceutical products.
- Benefits: Base salary $75,000–$103,000/yr; short-term incentive opportunity in first 12 months; comprehensive health/insurance benefits and 401(k) matching.
Essential Functions:
- Perform chemical analysis of raw materials, in-process, and finished pharmaceutical products (including stability) using written/compendial methods, material specifications, and techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatography per SOPs.
- Prepare samples and perform complex chromatographic analyses; maintain laboratory records (notebooks/computer-based), document steps, and calculate/report results timely.
- Participate in method transfer activities between facilities/organizations.
- Investigate out-of-specification (OOS) laboratory results, as required.
- Perform physical analysis using X-ray diffraction, DSC, and Malvern mastersizer.
- Prepare/execute method transfer protocols and method verification/validation protocols.
Additional Responsibilities:
- Assist senior scientists as needed.
- Remove expired chemicals/reference standards; calibrate dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, and GC as assigned.
- Standardize API for use as in-house reference standard.
- Train newly hired technicians/Assistant Scientists on basic analytical techniques and instruments.
Qualifications:
- Required: BS/BA in Chemistry or related science discipline.
- Preferred: MS/MA in Chemistry or related science discipline.
- Experience: 3+ years (BS/BA) testing chemicals/pharmaceutical products; 1+ year (MS/MA) testing chemicals/pharmaceutical products.
- Benefits: Base salary $75,000–$103,000/yr; short-term incentive opportunity in first 12 months; comprehensive health/insurance benefits and 401(k) matching.