Senior Scientist, Analytical R&D

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.