Amneal Pharmaceuticals

Scientist, Quality Control

Amneal Pharmaceuticals$70K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Chemistry or related discipline required; Master's Degree preferred.
  • Minimum of 3 years experience in testing of chemicals or pharmaceutical products with a Bachelor's; or at least 1 year with a Master's degree.
  • Strong background in analytical chemistry techniques, including spectroscopy and chromatography.
  • Knowledge of regulatory compliance and standard operating procedures (SOPs).
  • Experience in method transfer and investigation of out-of-specification results.

Responsibilities

  • Perform chemical analysis on raw materials, in-process, and finished products using SOPs and analytical techniques.
  • Prepare samples and maintain accurate laboratory documentation for procedures and results.
  • Lead and participate in method transfer activities across facilities or organizations.
  • Investigate out-of-specification laboratory results when necessary.
  • Conduct physical analysis using advanced techniques like X-ray diffraction and DSC.
  • Prepare and execute method transfer and validation protocols.
  • Train and assist new laboratory technicians on basic analytical methods.

Benefits

  • Opportunities for professional development and advancement within the organization.
  • Collaborative work environment with cross-functional teams.
  • Exposure to cutting-edge analytical techniques and technologies.
  • Access to a state-of-the-art laboratory and resources.
  • Ability to contribute to continuous improvement initiatives in the lab.
Full Job Description
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.


Qualifications

Education:
  • Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
  • Master Degree (MBA) Chemistry or related science discipline - Preferred

Experience:
  • 3 years or more in Bachelors Degree (BA/BS) -Testing of chemicals/pharmaceutical products, 3 years or more
  • 1 year or more in Master Degree (MA/MS) -Testing of chemicals/pharmaceutical products, 1 years or more


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About Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry. Today’s healthcare environment requires a new approach and new ideas. While staying true to our reputation for quality, service and value, we are reinventing our processes, our playbook and our creative partnerships. Our goal is simple: to be a healthy, growing company that endures for decades and that is an indispensable partner to the healthcare providers and patients we serve. Amneal is headquartered in Bridgewater, New Jersey.
Learn more about Amneal Pharmaceuticals
Size
7,000 employees
Market Cap
$616.6 million
Industry
Net Income
$91 million
5 Year Trend
+20.5%
Revenue
$1.9 billion
NASDAQ

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