Scientist - Analytical Chemistry

5w1 month ago

Amneal Pharmaceuticals

Brookhaven, US · Full-time · $83,000 – $103,000

About this role

This mid-level analytical scientist opportunity supports the analytical development of pharmaceutical oral dosage forms. The role fulfills a critical function in developing, validating, and transferring testing methods for the Quality Control laboratory to characterize drug substances, raw materials, and drug products.

Day-to-day responsibilities include performing physical and chemical analysis of raw materials, in-process samples, and finished pharmaceutical products, including stability samples, according to written methods and SOPs. The scientist also develops and validates analytical methods, primarily LC and GC, for active pharmaceutical ingredients, excipients, and dosage forms used in routine analysis.

As a member of the Quality Control Technical Services (QCTS) team, the scientist performs release testing of API, excipients, in-process and finished products, and stability study and cleaning verification samples. The individual provides training and guidance to laboratory analysts to expand the group's analytical capabilities and leads scientific discussions with cross-functional teams.

This position offers the opportunity to evaluate, recommend, and implement new analytical technologies and instrumentation. The scientist contributes to improving laboratory operations to increase efficiency and GMP compliance while staying abreast of new developments in analytical technologies.

Requirements

Broad knowledge of modern analytical equipment and techniques
In-depth knowledge of analytical chemistry techniques such as spectrophotometric, dissolution and drug release, and chromatographic techniques
Ability to measure physical parameters including viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, and identification by XRPD
3 years or more of pharmaceutical experience with a Bachelor's degree
1 year or more of pharmaceutical experience with a Master's degree
Experience complying with cGMPs, SOPs, and STPs to avoid out-of-specification situations
Ability to review laboratory analysis data for completeness, specification compliance, and compliance with company written policies

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
Develop and validate analytical methods (mostly LC and GC) for active pharmaceutical ingredients, excipients, and dosage forms for routine analysis
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
Provide training and guidance to laboratory analysts to develop technical capabilities within the Analytical Group
Document steps followed during analysis execution, calculate and report results, and actively participate in investigation of laboratory results
Evaluate, recommend, and implement new analytical technologies and instrumentation for testing
Assist the laboratory supervisor with non-routine special projects including out-of-specification and out-of-alert limit investigations

Benefits

Opportunity to work with state-of-the-art analytical instrumentation including HPLC, GC, dissolution apparatus, and spectroscopic tools
Role within a dedicated Quality Control Technical Services team focused on analytical development and method transfer
Chance to lead scientific discussions and mentor junior laboratory analysts
Involvement in evaluating and implementing new analytical technologies