Scientist, Analytical Chemistry
Amneal Pharmaceuticals
18 days ago
On-site
Branchburg, NJ
Clinical Research and Development
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 per written procedures and applicable SOPs. Calculates and reports results on specification documents and participates in method transfer activities within/between facilities or organizations. Provides feedback on systems and analytical procedures to support continuous improvement and compliance.
Essential Functions:
- Perform chemical analysis of raw materials and pharmaceutical products (including stability) using written/compendial methods and material specifications; analytical techniques may include IR spectroscopy, UV-Vis spectroscopy, and chromatography.
- Prepare and analyze samples using chromatographic techniques; maintain laboratory records (notebooks/computer-based), document steps, and calculate/report results timely.
- Participate in method transfer activities.
- Participate/lead investigations of out-of-specification (OOS) laboratory results (when required).
- Perform physical analysis using complex techniques (e.g., X-ray diffraction, DSC, Malvern mastersizer).
- Prepare and execute method transfer, and method verification/validation protocols (as required).
Additional Responsibilities:
- Assist senior scientists; ensure expired chemicals/reference standards are removed.
- Calibrate dissolution apparatus and instruments (FT-IR, UV-Vis, HPLC, GC) as assigned.
- Standardize API for in-house reference standard (as assigned).
- Train newly hired technicians/Assistant Scientists on basic analytical techniques and instruments.
Qualifications:
- Education: BA/BS in Chemistry or related science (Required); MS/MA or MBA in Chemistry or related science (Preferred).
- Experience: 3+ years (BA/BS) or 1+ year (Master’s) testing chemicals/pharmaceutical products.
Compensation/Benefits (if applicable):
- Base salary: $75,000–$103,000/year; short-term incentive opportunity in first 12 months.
- Comprehensive benefits program with health/insurance and 401(k) matching.
Essential Functions:
- Perform chemical analysis of raw materials and pharmaceutical products (including stability) using written/compendial methods and material specifications; analytical techniques may include IR spectroscopy, UV-Vis spectroscopy, and chromatography.
- Prepare and analyze samples using chromatographic techniques; maintain laboratory records (notebooks/computer-based), document steps, and calculate/report results timely.
- Participate in method transfer activities.
- Participate/lead investigations of out-of-specification (OOS) laboratory results (when required).
- Perform physical analysis using complex techniques (e.g., X-ray diffraction, DSC, Malvern mastersizer).
- Prepare and execute method transfer, and method verification/validation protocols (as required).
Additional Responsibilities:
- Assist senior scientists; ensure expired chemicals/reference standards are removed.
- Calibrate dissolution apparatus and instruments (FT-IR, UV-Vis, HPLC, GC) as assigned.
- Standardize API for in-house reference standard (as assigned).
- Train newly hired technicians/Assistant Scientists on basic analytical techniques and instruments.
Qualifications:
- Education: BA/BS in Chemistry or related science (Required); MS/MA or MBA in Chemistry or related science (Preferred).
- Experience: 3+ years (BA/BS) or 1+ year (Master’s) testing chemicals/pharmaceutical products.
Compensation/Benefits (if applicable):
- Base salary: $75,000–$103,000/year; short-term incentive opportunity in first 12 months.
- Comprehensive benefits program with health/insurance and 401(k) matching.