Lead Scientist, Quality Control

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Apply Job Description Description:

The Group Leader role performs testing or reviews records of testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculates and reports results on applicable specification documents, participates in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. The Group Leader also provides project leadership to a small group of scientists and guidance in the event of analytical problems.

Essential Functions:

Performs/Trains and Reviews chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques adhering to company policies as identified in standard operating procedures (SOPs). Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyze. Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and report results in a timely manner. Reviews/Interprets and evaluates data generated by co-workers for accuracy, precision, trends, potential GMP impact and completeness. Displays good laboratory techniques to avoid cross-contamination or mis-identification of samples. Ensure Scientist work assignments are prioritized to support project needs. Performs/Trains/Reviews physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer, RAMAN, ICPMS. Actively participates in and leads investigation of out-of-specification laboratory results, when required. Actively participates in method transfer activities between facilities within the organization or between organizations. Leads and tracks execution of method transfer protocols, method verification/validation protocols as and when required.

Additional Responsibilities:

Assists, as and when needed, laboratory supervisor for handling non-routine special projects requiring activities in the laboratory. Ensures that expired chemicals and reference standards are removed from the laboratory area, perform calibration of

HPLC, GC

as assigned by the Supervisor or Manager. Interacts with Lab Technicians and Scientists to provide hands-on training on basic analytical techniques and lab instruments.

Qualifications Education:

Bachelors Degree (BA/BS) Chemistry or related science discipline - Required Master Degree (MS/MA) Chemistry or related science discipline -

Preferred Experience:

5 years or more in Testing of pharmaceutical products ( with Bachelors), and 1 year of leading or supervising projects 3 years or more in Testing of pharmaceutical products ( With Masters) 1 year or more in Leading projects

Specialized Knowledge:

Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC). Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis. Must understand and apply cGMP requirements applicable to quality control laboratory. Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner. Must be able to identify trends in analytical data. Required Skills Analytical Testing Calibration Change Control Continuous Improvement Process First Article Inspections Good Manufacturing Practices Hand Tools Interpersonal Communications Investigation Quality Management Systems Regulatory Compliance Root Cause Analysis Strategic Decision Making Workflow Management About Us Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws. Apply Now Job Info Job Identification 7927 Job Category Quality Control Posting Date 05/11/2026, 08:09 PM Locations 1 New England Avenue, Piscataway, NJ, 08854, US Job Schedule Full time © MapTiler © OpenStreetMap contributors Legend Jobs at a location Group of locations © MapTiler © OpenStreetMap contributors | © Oracle Corporation Terms Legal Notices Use control and scroll to zoom the map Use two fingers to move the map 1 New England Avenue, Piscataway, NJ, 08854, US Copy to Clipboard Similar Jobs Scientist, Quality Control Piscataway, NJ, United States Posted on 03/27/2026 Trending The Scientist II - QC is responsible for performing chemical testing on raw materials, in-process and finished pharmaceutical products, including stability and cleaning verification samples, while ensuring compliance with SOPs and applicable specifications. This role also involves preparing samples, executing analytical techniques (e.g., IR, UV-Vis, chromatography), documenting results accurately, and supporting method transfers and continuous improvement initiatives. Data Reviewer-Senior Scientist, Quality Control Piscataway, NJ, United States Posted on 04/15/2026 Trending The Scientist 3 - QC is responsible to perform testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Inhalation Scientist, Analytical R D Piscataway, NJ, United States Posted on 04/09/2026 Trending The Scientist II is a mid-level analytical scientist who supports analytical development for oral solid dosage forms by performing method development, qualification, and validation, as well as testing APIs, excipients, and finished products in compliance with cGMP requirements. This role also maintains and qualifies analytical equipment, supports product development timelines, and contributes to continuous improvement through new technologies, documentation, and team training. See More Jobs