Job Description

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 sushma@intellectt.com or contact me directly at (732) 838-4956 .

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

Job Tags

Similar Jobs