Senior QC Scientist: Lead Analytics & Method Transfer

Operations; Piscataway Township (NJ); On-site; USD 110,000 - 130,000; Full time

Job summary

Amneal is seeking a Lead Scientist to perform and supervise chemical analysis of raw materials, in-process and finished pharmaceutical products, including stability samples. The role involves training staff, preparing samples, and maintaining complete lab records while ensuring compliance with SOPs and GMP requirements.

The candidate will review data, identify trends, and lead investigations of out-of-specification results.

Qualifications

• Bachelor's degree in Chemistry or related science required.
• Master's degree in Chemistry or related field preferred.
• 5+ years in testing of pharmaceutical products with Bachelor's, plus 1 year leading projects.
• 3+ years in testing with Master's degree.
• 1+ year leading projects.

Responsibilities

• Performs/Trains/Reviews chemical analysis of pharmaceutical materials and products using analytical techniques per SOPs.
• Prepares samples and maintains lab records; documents steps and reports results.
• Reviews/interprets data for accuracy, trends and GMP impact.
• Leads investigations of out-of-specification results and method transfer activities.

Skills

Analytical chemistry

GMP compliance

Data trend analysis

Laboratory leadership

Education

BA/BS Chemistry

MS Preferred

Tools

HPLC

GC

DSC

Malvern Mastersizer

RAMAN

ICP-MS

Job description

Amneal is seeking a Lead Scientist to perform and supervise chemical analysis of raw materials, in-process and finished pharmaceutical products, including stability samples. The role involves training staff, preparing samples, and maintaining complete lab records while ensuring compliance with SOPs and GMP requirements.

The candidate will review data, identify trends, and lead investigations of out-of-specification results.