Associate Scientist, Analytical Chemistry

2w2 weeks ago

Amneal Pharmaceuticals

Brookhaven, US · Full-time · $68,000 – $85,000

About this role

The Associate Scientist, Analytical Chemistry is an entry-level role that contributes to pharmaceutical analysis intended for drug product development. Preliminary activities include following schedules, compendia standards, and in-house standard operating procedures.

Day-to-day work involves analyzing pharmaceutical drug substances, excipients, and drug product testing for release and stability samples. The individual performs physical and chemical analysis of raw materials, in-process products, and finished pharmaceutical products, including stability studies.

This role is part of the Quality Control Technical Services team which performs release testing of API, excipients, raw materials, in-process and finished products, and cleaning verification samples. The individual follows written procedures and applicable SOPs, calculates results, and reports on specification documents.

The Associate Scientist evaluates and implements new analytical technologies and instrumentation. Stays abreast of new developments, leads team members on assigned projects, and participates in cross-functional scientific discussions to improve laboratory operations and GMP compliance.

Requirements

Knowledge of US FDA-cGMP and Standard Operating Procedures (SOPs).
Understanding of analytical chemistry and analytical laboratory procedures.
Background in modern analytical laboratory techniques including HPLC, GC, TLC, UV, and analytical equipment.
Ability to follow compendial (USP/EP/BP/JP) procedures for analysis.
Must understand and apply cGMP requirements applicable to a quality control laboratory.
Some experience in cGMP laboratory testing of pharmaceuticals.
Successful completion of an OSHA-compliant Respirator Fit Test required.
1 year or more of pharmaceutical experience.

Responsibilities

Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products according to written methods, material specifications, and SOPs.
Comply with cGMPs, SOPs, and STPs to avoid out-of-specification situations and assure compliance with state and federal regulations.
Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV and conductivity detection, TLC, pH meter, and dissolution apparatus.
Calibrate HPLC, dissolution apparatus, pH meters, analytical balances, and Karl-Fischer titrator.
Document steps during analysis execution, calculate and report results, and actively participate in investigation of laboratory results.
Review laboratory analysis data for completeness, specification compliance, and adherence to company policies.
Evaluate, recommend, and implement new analytical technologies and instrumentation for testing.
Lead team members on assigned projects and participate in scientific discussions with cross-functional teams.