Scientist, Quality Control
Amneal Pharmaceuticals
2 hours ago
On-site
Brookhaven, NY
Operations
Essential Functions:
- Perform chemical analysis of raw materials, in-process and finished pharmaceutical products (including stability samples) using written/compendial methods and material specifications; use techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques per SOPs.
- Prepare and analyze samples requiring cleanliness and complex steps (including chromatographic techniques); maintain laboratory records (notebooks/computer-based), document steps followed, and calculate/report results timely.
- Participate in method transfer activities between facilities or organizations.
- Participate in and lead investigations of out-of-specification (OOS) laboratory results, when required.
- Perform physical analysis using complex techniques such as X-ray diffraction, DSC, and Malvern mastersizer.
- Prepare and execute method transfer protocols and method verification/validation protocols as needed.
Additional Responsibilities:
- Assist senior scientists as needed.
- Remove expired chemicals and reference standards from the lab; perform calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, and GC as assigned.
- Standardize API for use as an in-house reference standard as assigned.
- Train newly hired laboratory technicians or Assistant Scientists on analytical techniques and laboratory instruments.
Qualifications:
- Education: BA/BS in Chemistry or related science discipline (Required); Master’s in Chemistry or related science discipline (Preferred).
- Experience: With BA/BS—3+ years testing chemicals/pharmaceutical products; with Master’s—1+ year testing chemicals/pharmaceutical products.
Compensation/Benefits (as stated):
- Base salary range: $75,000 to $103,000 per year.
- Comprehensive health/insurance benefits and 401(k) matching for eligible positions.
- Perform chemical analysis of raw materials, in-process and finished pharmaceutical products (including stability samples) using written/compendial methods and material specifications; use techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques per SOPs.
- Prepare and analyze samples requiring cleanliness and complex steps (including chromatographic techniques); maintain laboratory records (notebooks/computer-based), document steps followed, and calculate/report results timely.
- Participate in method transfer activities between facilities or organizations.
- Participate in and lead investigations of out-of-specification (OOS) laboratory results, when required.
- Perform physical analysis using complex techniques such as X-ray diffraction, DSC, and Malvern mastersizer.
- Prepare and execute method transfer protocols and method verification/validation protocols as needed.
Additional Responsibilities:
- Assist senior scientists as needed.
- Remove expired chemicals and reference standards from the lab; perform calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, and GC as assigned.
- Standardize API for use as an in-house reference standard as assigned.
- Train newly hired laboratory technicians or Assistant Scientists on analytical techniques and laboratory instruments.
Qualifications:
- Education: BA/BS in Chemistry or related science discipline (Required); Master’s in Chemistry or related science discipline (Preferred).
- Experience: With BA/BS—3+ years testing chemicals/pharmaceutical products; with Master’s—1+ year testing chemicals/pharmaceutical products.
Compensation/Benefits (as stated):
- Base salary range: $75,000 to $103,000 per year.
- Comprehensive health/insurance benefits and 401(k) matching for eligible positions.