Analytical Scientist: HPLC Method Development & QC

Prismhr Hire; Cranbury Township (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

Prismhr Hire in New Jersey is seeking an analytical chemist to support R&D scientists, conduct tests on raw materials, in-process materials, and finished products, and develop/validate HPLC methods. The role requires strong documentation and collaboration with QA and operations.

On-site work ensures adherence to cGMPs, USP/EP standards, and regulatory guidelines. The successful candidate will maintain data integrity, assist with OOS/OOT investigations, and contribute to environmental monitoring

Qualifications

• Bachelor’s Degree in Chemistry or relevant field with a minimum of 2 years of analytical laboratory experience.
• At least 2 years of experience with HPLC method development.
• Familiar with cGMPs, EU, 21 CFR Part 210, 211, and 820, and ISO.
• Strong background and understanding of USP, EP, other pharmacopeia.

Responsibilities

• Supports the Analytical Laboratory Services in the development and maintenance of the analytical laboratory and its practices and procedures.
• Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods.
• Develops, conducts, and validates various chemical assays.
• Develops, evaluates, and validates analytical methods for activities such as cleaning verification via HPLC.
• Collects and analyzes routine equipment cleaning verification/validation samples.
• Complies, interprets, and documents data from analytical tests.
• Troubleshoots analytical methods and equipment.
• Prepares Certificates of Analysis and analytical reports.
• Prepares and maintains raw data for review.
• Documents analyses in laboratory notebook, worksheets, or production batch records as applicable.
• Peer‑reviews laboratory records.
• Communicates quality or compliance concerns to Line Manager and Senior Management with urgency as applicable.
• Supports Out-of-Specification (OOS) or Out-of-Tolerance (OOT) laboratory investigations and communicate findings to Quality and Operations per internal SOPs.
• Supports environmental monitoring activities as required.
• Complies with Standard Operating Procedures (SOPs), cGMPs, and other regulatory standards as applicable.
• Performs other duties as assigned.

Skills

Communication skills

Dexterity

MS Office

Organization

SOP reading

Handwriting

Education

Bachelor's degree in Chemistry or relevant field

Tools

HPLC

Analytical instruments

Job description

Prismhr Hire in New Jersey is seeking an analytical chemist to support R&D scientists, conduct tests on raw materials, in-process materials, and finished products, and develop/validate HPLC methods. The role requires strong documentation and collaboration with QA and operations.

On-site work ensures adherence to cGMPs, USP/EP standards, and regulatory guidelines. The successful candidate will maintain data integrity, assist with OOS/OOT investigations, and contribute to environmental monitoring