HPLC Analytical Scientist - Pharma Lab & Methods

Astrix; Cranbury Township (NJ); On-site; USD 37,000 - 62,000; Full time

Job summary

Astrix in Cranbury, NJ is seeking an Analytical Scientist to perform routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

The role involves designing and validating analytical methods (including HPLC for cleaning verification), documenting results, preparing Certificates of Analysis, and ensuring compliance with cGMPs and regulatory standards.

Qualifications

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

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.
• Prepare Certificates of Analysis, analytical reports, and maintain lab documentation.
• Peer-review records and support OOS or OOT investigations as per SOPs.
• Ensure compliance with SOPs, cGMPs, and regulatory requirements.
• Assist with environmental monitoring and other tasks as assigned.

Skills

Analytical lab experience

Regulatory knowledge

Education

Bachelor's in Chemistry-related discipline

Tools

HPLC

Job description

Astrix in Cranbury, NJ is seeking an Analytical Scientist to perform routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

The role involves designing and validating analytical methods (including HPLC for cleaning verification), documenting results, preparing Certificates of Analysis, and ensuring compliance with cGMPs and regulatory standards.