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