Scientist, Analytical Chemistry

Amneal

2d•Onsite

About The Position

The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, and cleaning verification samples. This role involves calculating and reporting results on applicable specification documents and participating in method transfer activities. The position also contributes to continuous improvement by providing feedback on systems and analytical procedures. Essential Functions include performing chemical analysis using techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatography, preparing samples, maintaining laboratory records, leading investigations of out-of-specification results, and performing physical analysis using techniques like X-ray diffraction, DSC, and Malvern mastersizer. The role may also involve preparing and executing method transfer and validation protocols.

Requirements

Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
3 years or more in Bachelors Degree (BA/BS) - Testing of chemicals/pharmaceutical products
1 year or more in Master Degree (MA/MS) - Testing of chemicals/pharmaceutical products

Nice To Haves

Master Degree (MBA) Chemistry or related science discipline - Preferred

Responsibilities

Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs).
Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyzes.
Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
Actively participates in method transfer activities between facilities within the organization or between organizations.
Actively participates in and leads investigation of out-of-specification laboratory results, when required.
Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer.
Prepares and executes method transfer protocols, method verification/validation protocols as and when required.
Assists, as and when needed, senior scientists working in the laboratory.
Ensures that expired chemicals and reference standards are removed from laboratory area.
Performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, GC as assigned by the supervisor.
Standardizes API for use as in-house reference standard as assigned.
Interacts with newly hired laboratory technicians or Assistant Scientists for providing hands-on training on simple analytical techniques and laboratory instruments.