Associate Scientist, Analytical R&D

Amneal Pharmaceuticals LLC; Piscataway (MD); On-site; USD 65,000 - 80,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking an entry-level Scientist-I to contribute to pharmaceutical analysis for drug product development. You will perform analyses on drug substances, excipients, and product testing in line with USP/NF and EP methods and internal SOPs.

The role uses spectrophotometry, HPLC, GC, dissolution, and wet chemistry to generate data, interpret results, and support optimization of lab operations for GMP compliance.

Qualifications

• Bachelor's degree in Chemistry or related science.
• 1 year or more in pharmaceutical experience.
• Knowledge of US FDA-cGMP and SOPs.
• Experience with USP/NF, EP methods is a plus.

Responsibilities

• Perform quantitative analysis for drug substances, excipients and products using USP/NF, EP, SOPs.
• Utilize spectrophotometry, HPLC, GC, dissolution and wet chemistry tests.
• Interpret analytical results and communicate findings.
• Support troubleshooting and optimize laboratory operations for GMP compliance.

Skills

Spectrophotometry

Analytical chemistry

US FDA-cGMP knowledge

Result interpretation

Education

Bachelors in Chemistry or related science

Tools

HPLC

GC

TLC

UV spectrophotometry

Job description

Description:

The Scientist-I position is an entry level, and it contributes to tasks associated to pharmaceutical analysis intended for drug product development. The preliminary activities include following schedules, direction of compendia standards and in-house standard operating procedures to analyze pharmaceutical drug substance, excipients, drug product testing for release and stability samples.

Essential Functions:

• Perform quantitative analysis for pharmaceutical drug-substances, excipients and drug products using USP/NF, EP, in-house test methods and standard protocols, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
• -Utilize techniques of Spectrophotometry, HPLC, GC, dissolution, and wet chemistry tests in accordance with the USP.
• Interpret and communicate analytical results.
• Contribute to technical problem solving and troubleshooting as needed.
• Contribute towards optimizing laboratory operations to increase efficiency and GMP compliance.

Education:

• Bachelors Degree (BA/BS) Chemistry or related science - Required

Experience:

• 1 year or more in pharmaceutical experience

Specialized Knowledge:

• Knowledge of US FDA- cGMP and Standard Operating Procedures (SOP).
• Understanding of analytical chemistry and analytical laboratory procedures.
• Background of modern analytical laboratory techniques and use of HPLC, GC, TLC, UV, and analytical equipment.
• Some knowledge of analytical Method development.

The base salary for this position ranges from $65,000 to $80,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what 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, experience, geographic location and other relevant skills.

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.