Inhalation Scientist, Analytical R&D

Amneal • Piscataway Township, NJ

4d • $80,000 - $90,000

About The Position

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.

Requirements

• Analytical methods qualifications/validations
• Analyzes active pharmaceutical ingredients, excipients, and finished dosage forms using appropriate analytical methods
• Maintains/qualifies analytical equipment
• 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
• Performs methods validation
• Provides timely responses to all internal and external inquiries
• Ensures deadlines are met for product development schedules
• 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
• Stays abreast of new developments in analytical technologies
• Contributes to improvement in laboratory operations to increase efficiency and GMP compliance

Responsibilities

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed