Scientist, Analytical Chemistry

Amneal Pharmaceuticals LLC; Branchburg Township (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Scientist II - QC based in Branchburg Township, New Jersey. The role involves performing testing of raw materials and pharmaceutical products, participating in method transfers, and leading investigations of analytical results.

The ideal candidate will possess strong analytical skills with experience in various spectroscopy and chromatography techniques. This role plays a crucial part in ensuring product quality and compliance within a dynamic laboratory environment.

Qualifications

• Experience in performing chemical analysis of pharmaceutical products.
• Ability to adhere to standard operating procedures (SOPs).
• Proven skills in documenting laboratory processes.

Responsibilities

• Perform chemical analysis of raw materials and finished products.
• Prepare samples for analysis and maintain laboratory documentation.
• Participate in method transfer activities.

Skills

IR spectroscopy

UV-Vis spectroscopy

Chromatographic techniques

X-ray diffraction

HPLC

GC

Tools

Malvern mastersizer

Job description

Description

The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents, participating in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.

Essential Functions

• 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.

Additional Responsibilities

• 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.