GMP Lab Tech Team Lead

About the role

The GMP Lab Team Lead serves as the operational technical leader for daily cellular therapy manufacturing and laboratory activities within a highly regulated GMP environment. While remaining actively engaged in complex laboratory and manufacturing operations, this role provides day-to-day technical leadership, workflow coordination, and staff development to ensure the safe, efficient, and compliant production of clinical-grade cellular therapy products.

Responsibilities

• Provides technical leadership and workflow coordination for laboratory operations
• Assigns and prioritizes technical activities, supports manufacturing readiness, monitors workflow progression, and provides real-time technical guidance to laboratory staff
• Facilitates execution of cellular processing activities including aseptic manufacturing, cell isolation, expansion, enrichment, cryopreservation, analytical testing, and product release support
• Ensures compliance with cGMP, cGTP, biosafety, contamination control, and institutional quality requirements
• Serves as the first point of contact for technical troubleshooting, assists with resolution of manufacturing challenges, and escalates operational or personnel concerns to laboratory management as appropriate
• Develops staff technical competency through structured onboarding, training, direct observation, coaching, and competency assessment
• Serves as a resource for laboratory personnel by providing technical consultation, sharing subject matter expertise, and fostering consistency in manufacturing execution across all shifts and personnel
• Supports implementation of new manufacturing processes, equipment, analytical methods, and quality initiatives
• Contributes technical expertise to investigations, deviations, CAPAs, change controls, equipment qualification, process validation, environmental monitoring, inspection readiness, and continuous improvement activities
• Aids in evaluating workflow performance, identifying operational improvement opportunities, and implementing solutions that enhance efficiency, reliability, product quality, and patient safety

Requirements

• Master’s college degree with major in medical technology or biological sciences
• 5+ years clinical cell therapy experience
• 2+ years of leadership experience
• Experience working within an academic cGMP laboratory, including familiarity with FDA and FACT accreditation requirements
• Flow cytometry expertise
• Advanced hematology knowledge
• Motivation and initiative to learn new scientific theory and applications
• Mature judgment
• Work independently with regular review of progress and results
• Collaborate and communicate effectively across direct and indirect laboratory and clinical functions
• Highly experienced with documentation and data interpretation
• Serves as technical expert across multiple cell types
• Scientific writing skills, including preparation of clear, concise SOPs and technical reports
• Advanced math skills
• Advanced communication skills
• Differentiate between colors and pass a standardized color vision screen to perform this role

Qualifications

• Doctorate college degree with major in medical sciences or related field
• Cell selection operation experience (e.g., manual or CliniMACs)
• Moderate immunotherapy or regenerative medicine experience
• Strong experience with various LIS programs (e.g., Bluecord, Stemsoft)
• A masterful understanding of cGMP/cGTP standards

Skills

• Technical leadership and mentorship
• Workflow coordination and technical guidance
• Compliance with GMP and cGMP standards
• Collaboration and communication across laboratory and clinical functions
• Documentation and data interpretation
• Technical expertise across multiple cell types
• Scientific writing and report preparation
• Mathematical and communication skills
• Color differentiation and vision screening

Benefits

Not specified

Pay

Salary

Schedule

40 scheduled weekly hours