Senior Scientist, Analytical R&D

About the Role

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 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.

Responsibilities

• 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 and expanding analytical capabilities of the Analytical Group.
• Ensure that procedures are technically developed and conform to appropriate standards of identity, strength, quality, and purity of components.
• Evaluate, recommend, and implement new analytical technologies and instrumentation for testing.
• Stay abreast of new developments in analytical technologies.
• Contribute to improvement in laboratory operations to increase efficiency and GMP compliance.
• Lead team members on assigned projects, as required.
• Participate in and lead scientific discussions on projects with cross-functional teams.

Requirements

Education

• Bachelor’s Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences – Required
• Master’s 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 Master’s 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 standard operating procedures (SOPs) and test methods.
• Experience with regulatory document compilation.

Pay

The base salary for this position ranges from $90,000 to $110,000 per year. Individual compensation will ultimately be determined based on qualifications, geographic location, and other relevant skills.

Benefits

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 help you enjoy your career alongside life’s many other commitments and opportunities.