Analytical Scientist - QC & Methods Development

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

Job summary

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.

Responsibilities

• 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.

Skills

Analytical methods

Mass spectrometry

HPLC

GC

TLC

SOP writing

Education

Bachelor's Degree in Chemistry

Master's Degree in Chemistry

Tools

HPLC

GC

TLC

Mass Spectrometry

Job description

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.