Quality Control Analyst

Hello,

One of my clients is currently looking for a Senior Scientist – GLP/GMP Clinical Studies. If you're interested or if your skills align with the role, please share your updated resume with me at or contact me directly at .

Senior Scientist – GLP/GMP Clinical Studies

Location: Lawrenceville, NJ

Position Type: Contract (1 year, with possibility of extension)

Schedule: 8:00 AM to 5:00 PM (Flexible)

Key Requirements:

Education and Experience:

Bachelor's degree with a minimum of 5 years of relevant industry experience

Master's or PhD with 2–3 years of industry experience

Academic-only experience will not be considered

Mandatory Skills:

Strong hands-on experience with GLP

Proven experience in GLP/GMP clinical studies

Preferred (not required):

Experience with LC-MS

Must be able to start quickly and adapt with minimal training

Position Overview:

This role involves complex laboratory analysis of pharmaceutical and biopharmaceutical products, including method development, validation, and analytical testing in compliance with GLP/GMP regulations. The successful candidate will lead projects, interact with clients, and contribute to quality and regulatory compliance efforts.

Responsibilities:

Perform method validations, method transfers, and analytical testing of various pharmaceutical formulations

Prepare study protocols, status updates, final reports, and technical documentation

Communicate findings and technical issues directly with clients

Mentor junior staff and support laboratory troubleshooting

Conduct data analysis and ensure compliance with internal SOPs and external regulatory standards

Lead multiple concurrent projects and serve as the primary departmental contact

Ideal Candidate Profile:

Extensive experience in analytical chemistry within the pharmaceutical or CRO industry

Independent, detail-oriented, and able to manage diverse technical challenges

Strong understanding of regulatory requirements under GLP and GMP

Demonstrated ability to work cross-functionally and communicate effectively with internal teams and clients