Laboratory Manager — cGMP Methods & QA Lead

Experic; Cranbury Township (NJ); On-site; USD 125,000 - 155,000; Full time

Job summary

Experic in Cranbury, NJ seeks a senior analytical leader to manage laboratory activities from raw material testing through finished product release. You will lead a small team of analysts, ensuring regulatory compliance and timely product delivery.

You will develop, validate, and troubleshoot analytical methods (HPLC, GC, UV-Vis, FTIR, dissolution) with cross-functional teams, review data per GDP, and mentor staff while supporting regulatory inspections and CAPA resolutions.

Qualifications

• Bachelor’s or higher in chemistry or related field with substantial analytical lab experience.
• PhD plus >6 years in analytical roles is preferred.
• At least 3+ years of HPLC method development experience.
• Strong understanding of cGMP and regulatory guidelines (FDA/ICH/USP).
• Proven trouble-shooting and data review skills.
• Experience with method development, validation, and transfer.

Responsibilities

• Lead daily analytical operations in a hands-on capacity across materials, in-process, finished products, and stability studies.
• Develop, validate, and troubleshoot analytical methods (HPLC, GC, UV-Vis, FTIR, dissolution) with PDE/manufacturing.
• Review and approve analytical data and documentation per GDP standards.
• Investigate OOS/OOT, deviations, and CAPAs with scientific rationale.
• Maintain cGMP compliance in lab practices and regulatory requirements.
• Coordinate qualification, calibration, and maintenance of lab equipment.
• Create and update SOPs, test protocols, and work instructions.
• Mentor/train laboratory staff on technical skills and quality standards.
• Collaborate with Manufacturing, QA, PDE, BD for issue resolution.
• Support regulatory inspections with technical documentation and SME input.
• Oversee laboratory inventory and procurement of reagents and equipment.
• Promote continuous improvement to enhance lab performance.

Skills

Analytical leadership

cGMP knowledge

HPLC method development

Regulatory inspections support

Team mentoring

Data interpretation

Documentation accuracy

Education

Bachelor’s in Chemistry or related field

PhD with analytical exp >6 yrs

Tools

HPLC instruments

GC instruments

FTIR

UV-Vis

Job description

Experic in Cranbury, NJ seeks a senior analytical leader to manage laboratory activities from raw material testing through finished product release. You will lead a small team of analysts, ensuring regulatory compliance and timely product delivery.

You will develop, validate, and troubleshoot analytical methods (HPLC, GC, UV-Vis, FTIR, dissolution) with cross-functional teams, review data per GDP, and mentor staff while supporting regulatory inspections and CAPA resolutions.