Scientist, Quality Control

Description:

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.