Job DescriptionDescription:Research Scientist, Analytical Method Development fulfills a critical role in supporting the analytical development and validation of testing methods for the Analytical R&D laboratory, to characterize drug substance, raw materials, and drug products. The individual is a part of the Analytical Method Development team which develops, validates, and qualifies testing methods for active pharmaceutical ingredients, excipients and dosage forms, including reverse engineering of reference products.
Essential Functions:- Develop and validate analytical methods (mostly LC and GC) for active pharmaceutical ingredients, excipients and dosage forms to be used in the analytical R&D laboratory for routine analysis.
- Development and optimization of new and existing analytical methods for qualification, release testing of products
- Provide timely responses to internal and external inquiries.
- Provide training and guidance to laboratory analysts and group members aimed at developing technical capabilities. Expand analytical capabilities of the Analytical Group.
- Ensure that procedures are technically developed and conform to appropriate standards of identity, strength, quality, purity of components.
- Evaluate, recommend and implement new analytical technologies and instrumentation for testing
Additional Responsibilities:- Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.
- Leads team members on assigned projects, as required.
- Participates and leads scientific discussions on projects with cross-functional team.
QualificationsEducation:- Bachelors Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences - Required
- Master Degree (MS/MA) in chemistry or other relevant pharmaceutical sciences - Preferred
- Ph. D. in pharmaceutical sciences or related subject - Preferred
Experience:- 8 years or more in pharmaceutical experience (with Bachelor's Degree)
- 6 years or more in pharmaceutical experience (with Masters Degree)
- less than one year in pharmaceutical experience (with Ph.D.)
Specialized Knowledge:- Broad knowledge of modern analytical equipment and techniques.
- Extensive experience in cGMP laboratory testing. Hands-on experience with HPLC, GC, TLC, and MS.
- Method development and validation experience.
- Experience writing the standard operating procedures (SOPs) and test methods.
- Experience with regulatory document compilation.
The base salary for this position ranges from
$90,000 to $110,000 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.
