What are the responsibilities and job description for the Senior Scientist, Analytical R&D position at Amneal?
Description:
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.
Qualifications:
Education:
- 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.)
Skills:
- Enthusiasm and dedication performing as an individual contributor and in a team environment. - Intermediate
- Written and verbal communication and presentation skills. - Intermediate
- Ability to set priorities and to follow through on commitments utilizing organizational skills. - Intermediate
- Microsoft Office and ability to learn additional software/programs as needed. - Intermediate
- Ability to lead projects, and meet deadlines. - Intermediate
- Creativity to solve technical and compliance problems. - Intermediate
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.
