Senior Scientist, Quality Control
Amneal Pharmaceuticals
June 30, 2026
On-site
Piscataway, NJ
Operations
Senior Scientist, Quality Control
Responsibilities:
- Perform testing of raw materials, in-process and finished pharmaceutical dosage forms, stability samples, and cleaning verification samples per written procedures and applicable SOPs.
- Conduct physical and chemical analysis per methods/material specifications and company policies; comply with cGMP, SOPs, and STPs.
- Calculate and report results on applicable specification documents; document procedures and ensure technical/calc accuracy.
- Participate in method transfer; provide feedback to improve analytical systems/procedures and compliance.
- Perform process validation and cleaning validation/verification testing.
- Assist with troubleshooting complex analytical/instrument/software issues; support investigations of lab results (out-of-specification and out-of-alert limit as assigned).
- Review lab data for completeness and specification compliance; report abnormal findings to the Supervisor.
- Ensure expired chemicals/reference standards are removed; perform equipment calibrations as assigned (HPLC, GC, etc.).
- Assist with special projects and hands-on training of Technicians/Scientists 1–2.
- Participate in assigned project work.
Required/Qualifications:
- In-depth analytical chemistry knowledge (spectrophotometric, dissolution/drug release, chromatographic techniques; physical parameter testing such as laser diffraction, DSC melting point, TGA water content, XRPD, etc.).
- Ability to follow compendial procedures (USP/EP/BP/JP).
- Understand and apply cGMP requirements for QC laboratory.
- Advanced skills to troubleshoot/resolution complex analytical and instrument problems; identify trends in analytical data.
- Bachelor’s degree in Pharmacy, Chemistry, or Pharmaceutical Manufacturing.
- 60 months of experience in the position or related position.
Skills/Tools (examples used): sonic sifter, laser diffraction, Karl Fischer, UV-Vis/IR spectrophotometers, HPLC (UV and conductivity), TLC, pH meter, dissolution.
Location/Hours/Pay:
- Piscataway, NJ; 40 hrs/wk (8:30am–5:30pm); $115K–$120K per annum.
Responsibilities:
- Perform testing of raw materials, in-process and finished pharmaceutical dosage forms, stability samples, and cleaning verification samples per written procedures and applicable SOPs.
- Conduct physical and chemical analysis per methods/material specifications and company policies; comply with cGMP, SOPs, and STPs.
- Calculate and report results on applicable specification documents; document procedures and ensure technical/calc accuracy.
- Participate in method transfer; provide feedback to improve analytical systems/procedures and compliance.
- Perform process validation and cleaning validation/verification testing.
- Assist with troubleshooting complex analytical/instrument/software issues; support investigations of lab results (out-of-specification and out-of-alert limit as assigned).
- Review lab data for completeness and specification compliance; report abnormal findings to the Supervisor.
- Ensure expired chemicals/reference standards are removed; perform equipment calibrations as assigned (HPLC, GC, etc.).
- Assist with special projects and hands-on training of Technicians/Scientists 1–2.
- Participate in assigned project work.
Required/Qualifications:
- In-depth analytical chemistry knowledge (spectrophotometric, dissolution/drug release, chromatographic techniques; physical parameter testing such as laser diffraction, DSC melting point, TGA water content, XRPD, etc.).
- Ability to follow compendial procedures (USP/EP/BP/JP).
- Understand and apply cGMP requirements for QC laboratory.
- Advanced skills to troubleshoot/resolution complex analytical and instrument problems; identify trends in analytical data.
- Bachelor’s degree in Pharmacy, Chemistry, or Pharmaceutical Manufacturing.
- 60 months of experience in the position or related position.
Skills/Tools (examples used): sonic sifter, laser diffraction, Karl Fischer, UV-Vis/IR spectrophotometers, HPLC (UV and conductivity), TLC, pH meter, dissolution.
Location/Hours/Pay:
- Piscataway, NJ; 40 hrs/wk (8:30am–5:30pm); $115K–$120K per annum.