Analytical Scientist: HPLC, cGMP & Validation

Astrix Inc.; Cranbury Township (NJ); On-site; USD 52,000 - 62,000; Full time

Job summary

Astrix Inc. is seeking an Analytical Scientist to join our pharmaceutical manufacturing team in New Jersey.

The candidate will perform routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples, ensuring compliance with SOPs and regulatory requirements. The role involves designing and validating analytical methods (including HPLC for cleaning verification) and preparing Certificates of Analysis and analytical reports.

Qualifications

• 2 years hands-on method development experience with HPLC.
• Knowledge of cGMPs, pharmacopeia (USP, EP), and regulatory standards (21 CFR Part 210/211/820, ISO).
• Bachelor's in Chemistry-related discipline with 2+ years of analytical lab experience.

Responsibilities

• Conduct and document chemical analyses for raw materials, in-process goods, and finished products.
• Design, validate, and resolve issues with analytical methods, including HPLC for cleaning verification.
• Collect and analyze equipment cleaning validation samples.

Skills

HPLC method development

cGMP knowledge

Regulatory standards awareness

Education

Bachelor's in Chemistry-related discipline

Job description

Astrix Inc. is seeking an Analytical Scientist to join our pharmaceutical manufacturing team in New Jersey.

The candidate will perform routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples, ensuring compliance with SOPs and regulatory requirements. The role involves designing and validating analytical methods (including HPLC for cleaning verification) and preparing Certificates of Analysis and analytical reports.