Scientist II, AR & D (Biotech)

Job Summary

The Scientist-2 is a mid-level analytical scientist opportunity supporting the analytical development of pharmaceutical oral dosage form. The individual in this capacity performs analytical methods qualifications/validations, analyzes active pharmaceutical ingredients, excipients, and finished dosage forms using appropriate analytical methods  and maintains/qualifies analytical equipment.

Essential Functions

• Performs analysis and release of active pharmaceutical ingredients, excipients, in-process materials, and finished drug products to support the formulation development team, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
• Develops and optimizes new and existing analytical methods for qualification and release testing of products. Develops stability indicating methods and performs methods validation.
• Provides timely responses to all internal and external inquiries.
• Ensures deadlines are met for product development schedules, and checks that technical and compliance requirements are met.
• Evaluates, recommends, and implements new analytical technologies and instrumentation for testing.
• Assists with training other members of the analytical development team.

Additional Responsibilities

• Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.

Education

• Bachelors Degree (BA/BS) in Chemistry or related science - Required
• Master Degree (MS/MA) in Chemistry or related science - Preferred

Work Experience

• 3 years or more of pharmaceutical experience (with Bachelor's Degree) - Required
• 1 year or more of pharmaceutical experience (with Master's Degree) - Required

Skills and Abilities

• Enthusiasm and dedication to learn and adopt new analytical techniques. - 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
• Meet deadlines under pressure. - Intermediate
• Able to work in a team environment. - 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.
• Methods development experience.
• Experience writing the standard operating procedures (SOPs) and test methods.