Senior Scientist - Analytical Chemistry

2w2 weeks ago

Amneal Pharmaceuticals

Brookhaven, US · Full-time · $93,000 – $123,000

About this role

This role is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, as well as products on stability and cleaning verification samples. The scientist will follow written procedures and applicable SOPs, calculate and report results on specification documents, and participate in method transfer activities within departments or between facilities.

Day-to-day work involves physical and chemical analysis using techniques such as HPLC with UV and conductivity detection, UV-Vis spectrophotometry, Karl Fischer titration, laser diffraction, and dissolution testing. The scientist will also calibrate instruments including HPLC, dissolution apparatus, pH meters, analytical balances, and Karl-Fischer titrators, and document all steps during analysis execution.

The role actively participates in project work, process validation, and cleaning validation/verification testing on various drugs. The scientist will assist other scientists with analytical, instrument, and software-related problems, and review laboratory analysis data for completeness, specification compliance, and adherence to company policies.

This position offers the opportunity to assist with hands-on training of newly hired technicians or scientists at the 1 and 2 levels. The scientist will also support the laboratory supervisor with non-routine special projects, including out-of-specification and out-of-alert limit investigations, contributing to continuous improvement and compliance enhancement.

Requirements

In-depth knowledge of analytical chemistry techniques including spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hyphenated), and measuring physical parameters (viscosity, particle size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD)
Ability to follow compendial (USP/EP/BP/JP) procedures for analysis
Understanding and application of 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
Experience with HPLC, GC, UV-Vis, IR, Karl Fischer, dissolution, and other analytical instrumentation
Proficiency in using sonic sifter, laser diffraction, TLC, pH meter, and analytical balances

Responsibilities

Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods and SOPs
Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, IR spectrophotometer, HPLC with UV and conductivity detection, TLC, pH meter, and dissolution apparatus
Calibrate HPLC, dissolution apparatus with auto-sampler and/or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator
Document steps followed during analysis execution, calculate and report results, and actively participate in investigation of laboratory results
Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies
Assist the laboratory supervisor with non-routine special projects including out-of-specification and out-of-alert limit investigations
Perform process validation and cleaning validation/verification testing on various drugs, and assist other scientists with analytical, instrument, and software-related problems
Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels

Benefits

Opportunity to participate in method transfer activities within departments or between facilities or organizations
Hands-on training of newly hired Technicians or Scientists 1 and 2 levels
Involvement in non-routine special projects including out-of-specification and out-of-alert limit investigations
Chance to provide feedback on systems and analytical procedures to promote continuous improvement and compliance enhancement