Scientist, Quality Control

Amneal Pharmaceuticals; Town of Brookhaven (NY); On-site; USD 75,000 - 103,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Comprehensive benefits

Job summary

Amneal Pharmaceuticals in Brookhaven, NY is seeking a Scientist II - QC to perform testing of raw materials, in-process and finished dosage forms, including stability and cleaning verification, using IR, UV-Vis, and chromatography. You will document results and contribute to SOPs.

The role requires a BA/BS in chemistry (or related) with 3+ years experience; Master's preferred. You will participate in method transfers and investigations of out-of-spec results, and support calibration and

Qualifications

• Bachelor's degree in Chemistry or related science is required.
• Master's degree is preferred.
• OSHA respirator fit test completed.

Responsibilities

• Performs chemical analysis of materials and products using SOPs and compendial methods.
• Prepares samples, documents steps, and reports results promptly.
• Participates in method transfer activities between facilities.
• Investigates out-of-specification results and collaborates on root cause.
• Maintains and calibrates instruments (HPLC, GC, FT-IR, UV-Vis, etc.).

Skills

Attention to detail

Analytical thinking

Team collaboration

Education

Bachelor's Degree in Chemistry or related science

Master's Degree in Chemistry or related science (preferred)

Tools

HPLC

GC

FT-IR

UV-Vis

X-ray diffraction

DSC

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.

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:

• Bachelor's Degree (BA/BS) Chemistry or related science discipline - Required
• Master's degree (MBA) Chemistry or related science discipline - Preferred
  

Experience:
Experience:

• With Bachelor's Degree (BA/BS) -Testing of chemicals/pharmaceutical products, 3 years or more
• With Master's degree (MA/MS) -Testing of chemicals/pharmaceutical products, 1 years or more

Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.

The base salary for this position ranges from $75,000 to $103,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.
About Us
Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.