Scientist, Analytical R&D

RXinsider LTD.; Piscataway Township, Northern (NJ, KY); Hybrid; USD 75,000 - 90,000; Full time

Benefits offered by this job

Bonus program

Incentive opportunity

Job summary

Amneal is seeking a mid-level Scientist-2 to support analytical development of pharmaceutical oral dosage forms. The role involves qualifying/validating analytical methods, analyzing APIs, excipients, and finished dosage forms, and maintaining analytical equipment in a cGMP environment.

Responsibilities include developing and validating methods for qualification and release, providing timely responses to inquiries, and ensuring development deadlines are met while adopting new technologies.

Qualifications

• Bachelor's degree in Chemistry or related field required
• 3+ years pharma experience with Bachelor's; 1+ year with Master's preferred

Responsibilities

• Performs analysis and release of APIs, excipients, in-process materials, and finished drug products to support formulation development in compliance with cGMP and SOPs.
• Develops and optimizes new analytical methods for qualification and release testing; performs method validation and stability-indicating studies.
• Provides timely responses to internal and external inquiries and ensures deadlines for development schedules are met.
• Evaluates, recommends, and implements new analytical technologies and instrumentation for testing.
• Assists with training other analytical development team members.
• Stays abreast of new developments in analytical technologies and contributes to GMP-compliant lab operations.

Skills

GMP knowledge

Methods development

SOP writing

Analytical equipment know-how

Education

Bachelor's in Chemistry or related science

Master's in Chemistry or related science

Tools

HPLC

GC

TLC

MS

Job description

Job 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.