Scientist, Analytical Chemistry

Amneal•Branchburg Township, NJ

About The Position

The Scientist, Analytical Chemistry is a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. This role fulfills a critical function in supporting the analytical development, validation/verification, and method transfer of testing methods for the Quality Control laboratory. The position involves characterizing drug substance, raw materials, and drug products. The individual will be part of the Quality Control Technical Services (QCTS) team, responsible for performing release testing of API, Excipients/raw materials, In-process and Finished products, and stability studies, as well as analyzing cleaning verification samples. This will be done following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents.

Requirements

Bachelors Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences - Required
3 years or more in pharmaceutical experience (with Bachelor's Degree)
Broad knowledge of modern analytical equipment and techniques.
In-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques).
Ability to follow compendial (USP/EP/BP/JP) procedures for analysis.
Understanding and application of cGMP requirements applicable to quality control laboratory.
Extensive experience in cGMP laboratory testing of pharmaceuticals.
Hands-on experience with HPLC, GC, Dissolution Apparatus, UV Spectrophotometer, FTIR, TLC, and MS.
Method development and validation experience.
Experience writing standard operating procedures (SOPs) and test methods.
Experience with regulatory document compilation.

Nice To Haves

Master Degree (MS/MA) in chemistry or other relevant pharmaceutical sciences - Preferred
1 year or more in pharmaceutical experience (with Master's Degree)

Responsibilities

Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (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 detection as well as with conductivity detection, TLC, pH meter, and dissolution apparatus.
Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator.
Develop and validate analytical methods (mostly LC and GC) for active pharmaceutical ingredients, excipients and dosage forms to be used in the analytical laboratory for routine analysis.
Develop and optimize new and existing analytical methods for qualification and release testing of products.
Provide training and guidance to laboratory analysts and group members aimed at developing technical capabilities.
Expand analytical capabilities of the Analytical Group.
Document steps followed during analysis execution, calculate and report results.
Actively participate in the investigation of laboratory results.
Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies.
Provide timely responses to internal and external inquiries.
Evaluate, recommend and implement new analytical technologies and instrumentation for testing.
Stay abreast of new developments in analytical technologies.
Contribute to improvement in laboratory operations to increase efficiency and GMP compliance.
Lead team members on assigned projects, as required.
Participate and lead scientific discussions on projects with cross-functional teams.
Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory.