Scientist, Analytical R&D (Biotech)
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.
Education:
- Bachelors Degree (BA/BS) Chemistry or related science - Required
- Master Degree (MS/MA) Chemistry or related science - Preferred
Experience:
- 3 years or more in pharmaceutical experience (with Bachelor's Degree)
- 1 year or more in pharmaceutical experience (with Master's Degree)
Skills:
- 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.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
