Senior Scientist - Quality Control

4h4 hours ago

Amneal Pharmaceuticals

Brookhaven, US · Full-time · $85,000 – $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 includes physical and chemical analysis using techniques such as HPLC with UV and conductivity detection, UV-Vis spectrophotometry, Karl Fischer titration, dissolution testing, and laser diffraction. The scientist will also calibrate instruments like HPLC, dissolution apparatus, pH meters, and analytical balances, 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 may provide hands-on training to newly hired Technicians or Scientists at the 1 and 2 levels.

This position offers the opportunity to contribute to continuous improvement and enhancement of the compliance posture by providing feedback on systems and analytical procedures. The scientist will also assist the laboratory supervisor with non-routine special projects, including out-of-specification and out-of-alert limit investigations.

Requirements

Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, and chromatographic techniques (standalone or hyphenated)
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
5 years or more with Bachelors Degree in testing of chemicals/pharmaceutical products
3 years or more with Masters Degree in testing of chemicals/pharmaceutical products

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 handling non-routine special projects such as out-of-specification and out-of-alert limit investigations
Ensure expired chemicals and reference standards are removed from the laboratory area
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
Involvement in process validation and cleaning validation/verification testing on various drugs
Chance to contribute to continuous improvement and enhancement of compliance posture
Hands-on training and mentorship of junior scientists and technicians