Associate Scientist, Analytical R&D

Merck & Co.; Piscataway Township (NJ); On-site; USD 65,000 - 80,000; Full time

Job summary

Amneal is seeking an entry-level Scientist I to contribute to pharmaceutical analysis for drug product development. The role involves following schedules, SOPs, and conducting analysis of drug substances, excipients, and drug products for release and stability testing.

Candidates should have a BA/BS in chemistry or related science and at least one year of pharmaceutical experience. Knowledge of cGMP, USP/EP methods, and modern analytical techniques is required; strong data interpretation skills

Qualifications

• Bachelor's degree in Chemistry or related science required.
• Minimum 1 year of pharmaceutical experience.
• Knowledge of US FDA cGMP and SOPs.
• Experience with analytical techniques and laboratory procedures.
• Familiarity with method development is a plus.

Responsibilities

• Perform quantitative analysis of drug substances, excipients, and drug products per USP/EP and in-house methods.
• Interpret and communicate analytical results to ensure compliant release and stability testing.
• Support optimization of lab operations to improve GMP compliance.
• Maintain compliance with cGMP, SOPs, and internal schedules.

Skills

Analytical chemistry knowledge

cGMP SOP knowledge

Spectrophotometry

HPLC

GC

Dissolution

Wet chemistry

Data interpretation

Education

Bachelor's in Chemistry

Tools

Spectrophotometry

HPLC

GC

Dissolution

Wet chemistry

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.