Analytical Sciences Lab Lead – HPLC/UPLC & Data Review
About The Position
We are seeking a hands-on Analytical Sciences Lab Lead with strong expertise in HPLC/UPLC testing and GMP data review to support laboratory operations in a fast-paced, compliance-driven environment. This role is ideal for a scientist who enjoys staying connected to the bench while playing a critical role in ensuring the accuracy, integrity, and compliance of analytical data. The Lab Lead will be responsible for both executing and reviewing analytical work, with a strong emphasis on data verification, audit trail review, and Good Documentation Practices (GDP). In addition to technical responsibilities, this individual will lead and develop a team, helping ensure high-quality output, strong compliance practices, and efficient lab operations. The position requires a proactive leader who can bridge hands-on testing with detailed data review oversight.
Requirements
- Bachelor’s degree in Chemistry or related scientific field
- 2+ years of cGMP data review experience (required)
- 2+ years of leadership or team coordination experience
- Strong hands-on experience with HPLC/UPLC and chromatographic data analysis
- Deep understanding of data integrity principles, audit trails, and GDP
- Strong attention to detail with the ability to identify inconsistencies in analytical data
- Effective communicator with strong organizational and multitasking skills
- Ability to work both at the bench and in a data review capacity
Nice To Haves
- Experience with UV-Vis
- Exposure to ELISA, MCE, or iCIEF preferred
Responsibilities
- Perform and support HPLC/UPLC and other analytical testing in a GMP laboratory
- Conduct thorough review of analytical data to ensure accuracy, completeness, and compliance with SOPs and regulatory requirements
- Review chromatographic data, calculations, sequences, and system suitability results
- Verify audit trails, integration, and proper system usage
- Ensure chain of custody and sample traceability throughout testing processes
- Review and maintain lab notebooks, logbooks, and electronic records in accordance with GDP
- Identify, investigate, and resolve data discrepancies or deviations in collaboration with lab staff
- Lead, mentor, and develop a team of analysts and data reviewers
- Balance team workload across testing and data review activities
- Support training, onboarding, and skill development, particularly in data integrity and chromatography
- Monitor and report on quality metrics, turnaround times, and productivity
- Serve as a key point of contact between lab staff, management, and clients
- Promote a culture of quality, accountability, and continuous improvement
- Ensure adherence to cGMP, GLP, and internal procedures
- Perform audit trail reviews and documentation checks to support data integrity initiatives
- Conduct laboratory walkthroughs and compliance checks
- Support internal and external audits as needed
- Maintain a strong focus on data integrity, documentation accuracy, and regulatory readiness
Benefits
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
