Scientist, Analytical R&D

Amneal Pharmaceuticals LLC; Piscataway (MD); On-site; USD 75,000 - 90,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Scientist-2 in Maryland to support analytical development for pharmaceutical oral dosage forms. The role involves qualifying and validating analytical methods, analyzing API/excipients/finished dosage forms, and maintaining analytical equipment.

Responsibilities include method development, release testing, timely inquiry responses, and ensuring GMP and SOP compliance. Experience with HPLC, GC, TLC, and MS is valued.

Qualifications

• Bachelor’s degree in Chemistry or related science is required
• Master’s degree in Chemistry or related science is preferred
• 3+ years pharmaceutical experience with BS, 1+ year with MS

Responsibilities

• Performs analysis and release of API, excipients, in-process materials, and finished drug products to support formulation development, complying with cGMP and SOPs
• Develops and optimizes analytical methods for qualification and release testing of products
• Provides timely responses to internal and external inquiries
• Ensures deadlines are met for product development schedules and that technical and compliance requirements are met
• Evaluates, recommends, and implements new analytical technologies and instrumentation

Job description

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)

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.

The base salary for this position ranges from $75,000 to $90,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail]. Requests will be handled confidentially and in accordance with applicable laws.