Senior Scientist, Analytical R&D (Biotech)

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.

 

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.

 

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.