Manager, Analytical Chemistry

5w1 month ago

Amneal Pharmaceuticals

US · Full-time · $129,000 – $135,000

About this role

Amneal Pharmaceuticals seeks a Manager, Analytical QC to lead the quality control technical service group, ensuring the quality and compliance of laboratory operations for pharmaceutical products. This role oversees testing activities, method development, validation, verification, and transfer for commercial market products.

Day-to-day responsibilities include managing the Laboratory Technical Service group, assigning project work, and ensuring testing attributes for method validation and verification align with current ICH guidance. The manager enforces laboratory GMP systems, monitors compliance with USP general chapters and monographs, and coordinates method validation or verification as needed.

The role collaborates with cross-functional teams to support strategic planning and project delivery, communicating the impact of Analytical QC activities to appropriate personnel. The manager also reviews new source DMFs, evaluates method validations, and leads periodic reviews of commercial methods to ensure ruggedness and compliance with current standards.

This position offers the opportunity to contribute to employee development through promotion and salary increase recommendations, while applying advanced technical skills to troubleshoot complex analytical and instrument-related problems. The role is based in Piscataway and Branchburg, NJ, with a salary range of $129K to $135K per annum.

Requirements

In-depth knowledge of method development, method validation, method verification, and analytical chemistry techniques such as spectrophotometric, dissolution, drug release, and chromatographic techniques (standalone or hyphenated).
Ability to measure physical parameters including viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques.
Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
Must understand and apply cGMP requirements applicable to a quality control laboratory.
Ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner.
Must be able to identify trends in analytical data.
Must have at least a bachelor's degree in pharmacy, chemistry, or pharmacology.
Must have 12 months of experience in the position or in a related position.

Responsibilities

Manage the activities of the quality control technical service to ensure quality and compliance of laboratory operations for pharmaceutical products.
Oversee testing activities, method development, method validation, compendial/non-compendial method verification, and method transfer.
Collaborate with cross-functional teams and ensure regulatory compliance with cGMP.
Manage day-to-day operations of Analytical QC activities, including work assignment of projects.
Review new source DMFs and evaluate method validations and methods prior to validation.
Monitor and evaluate proposed changes to USP general chapters and monographs, and perform or coordinate method validation/verification to maintain compliance.
Lead periodic review of current commercial methods to ensure validation documents meet current standards and support continued use.
Provide input on yearly department headcount and employee development, including promotion and salary increase recommendations.

Benefits

Salary range of $129K to $135K per annum.
Standard work schedule of 40 hours per week, 8:30am to 5:30pm.
Equal Opportunity Employer with consideration for all qualified applicants.
Reasonable accommodation available for the application process or hiring process upon request.