Scientist, Quality Control

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); Sur place; USD 75 000 - 90 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC in New Jersey seeks a mid-level Scientist-2 to support analytical development of oral dosage forms. The role performs method qualification/validation, analyzes API, excipients, and finished products, and maintains analytical equipment in compliance with US FDA cGMP.

Responsibilities include developing and optimizing methods, stability-indicating assays, responding to inquiries, meeting development deadlines, evaluating new technologies, and training team members.

Qualifications

• Bachelor's degree in Chemistry or related science required.
• Master's degree in Chemistry or related science preferred.
• 3+ years pharmaceutical experience with Bachelor's degree.
• 1+ year pharmaceutical experience with Master's degree.

Responsabilités

• Perform analysis and release of APIs, excipients, in-process materials, and finished drug products to support formulation development under cGMP.
• Develop and optimize analytical methods for qualification and release testing; create stability-indicating methods.
• Provide timely responses to internal and external inquiries.
• Ensure deadlines are met for product development schedules and that technical and compliance requirements are satisfied.
• Evaluate, recommend, and implement new analytical technologies and instrumentation.
• Assist with training other members of the analytical development team.

Connaissances

Analytical methods

Mass spectrometry

HPLC

GC

TLC

SOP writing

Formation

Bachelor's Degree in Chemistry

Master's Degree in Chemistry

Outils

HPLC

GC

TLC

Mass Spectrometry

Description du poste

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.

Qualifications

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.

About Us

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.