Manager, Analytical Chemistry
Amneal Pharmaceuticals
July 02, 2026
On-site
Branchburg, NJ
Operations
Responsibilities:
- Manage the Quality Control (Analytical QC) technical service to ensure quality and cGMP compliance for pharmaceutical laboratory operations.
- Oversee testing activities, method development, method validation, compendial/non-compendial method verification, and method transfer.
- Lead the Laboratory Technical Service group to ensure method validation/verification/transfer testing attributes follow current ICH guidance.
- Manage day-to-day Analytical QC operations, including project work assignment.
- Collaborate with cross-functional teams; communicate potential impacts of Analytical QC activities in a timely manner.
- Review new source DMFs and evaluate method validations/methods prior to validation.
- Enforce/sustain laboratory GMP systems and maintain USP compliance, including monitoring USP general chapter/monograph changes and performing/coordination validation/verification as needed.
- Lead periodic review of current commercial methods to ensure validation documents meet current standards and are “rugged” for commercial use.
- Review method validation reports, specifications, and supplement submission documents.
- Provide input on yearly department headcount and employee development (promotion/salary increases).
Qualifications/Skills:
- In-depth knowledge of method development/validation/verification and analytical chemistry techniques (spectrophotometric, dissolution/drug release, chromatographic—standalone or hyphenated; physical parameter measurements: viscosity, particle/droplet size by laser diffraction, melting point by DSC, water content by TGA, XRPD identification, etc.).
- Ability to follow compendial procedures (USP/EP/BP/JP) and apply cGMP requirements.
- Advanced troubleshooting skills for complex analytical and instrument-related problems; identify analytical data trends.
- Bachelor’s degree in pharmacy, chemistry, or pharmacology.
- 12 months experience in the position or related position.
Application/Posting Info:
- Salary: $129K–$135K per annum. Hours: 40 hrs./wk, 8:30am–5:30pm. Location: Piscataway and Branchburg, NJ. Ref # 12519.
- Manage the Quality Control (Analytical QC) technical service to ensure quality and cGMP compliance for pharmaceutical laboratory operations.
- Oversee testing activities, method development, method validation, compendial/non-compendial method verification, and method transfer.
- Lead the Laboratory Technical Service group to ensure method validation/verification/transfer testing attributes follow current ICH guidance.
- Manage day-to-day Analytical QC operations, including project work assignment.
- Collaborate with cross-functional teams; communicate potential impacts of Analytical QC activities in a timely manner.
- Review new source DMFs and evaluate method validations/methods prior to validation.
- Enforce/sustain laboratory GMP systems and maintain USP compliance, including monitoring USP general chapter/monograph changes and performing/coordination validation/verification as needed.
- Lead periodic review of current commercial methods to ensure validation documents meet current standards and are “rugged” for commercial use.
- Review method validation reports, specifications, and supplement submission documents.
- Provide input on yearly department headcount and employee development (promotion/salary increases).
Qualifications/Skills:
- In-depth knowledge of method development/validation/verification and analytical chemistry techniques (spectrophotometric, dissolution/drug release, chromatographic—standalone or hyphenated; physical parameter measurements: viscosity, particle/droplet size by laser diffraction, melting point by DSC, water content by TGA, XRPD identification, etc.).
- Ability to follow compendial procedures (USP/EP/BP/JP) and apply cGMP requirements.
- Advanced troubleshooting skills for complex analytical and instrument-related problems; identify analytical data trends.
- Bachelor’s degree in pharmacy, chemistry, or pharmacology.
- 12 months experience in the position or related position.
Application/Posting Info:
- Salary: $129K–$135K per annum. Hours: 40 hrs./wk, 8:30am–5:30pm. Location: Piscataway and Branchburg, NJ. Ref # 12519.