Lab Technician

Lab Technician Gmp Manufacturing

This Lab Technician role focuses on the manufacturing, processing, quality support, and distribution of porcine islet and encapsulated islet combination products within a GMP-regulated cleanroom environment. You will perform highly specialized laboratory and manufacturing activities, ensure product quality, support regulatory compliance, and consistently apply aseptic processing standards. Working within established SOPs and Good Manufacturing Practices (GMP), you will maintain accurate documentation, operate specialized laboratory equipment, contribute to quality initiatives, and support the daily operation of a growing GMP manufacturing facility that produces an innovative therapy for people with Type 1 diabetes.

Responsibilities

• Perform manufacturing and processing activities in a controlled cleanroom environment using aseptic and sterile techniques.
• Operate specialized manufacturing and laboratory equipment, including cell processing systems, encapsulation equipment, microscopy tools, and cell-counting instrumentation.
• Prepare reagents, solutions, and materials required for manufacturing operations and laboratory testing activities.
• Complete batch records, logbooks, deviation reports, and production documentation accurately, contemporaneously, and in accordance with Good Documentation Practices (GDP).
• Maintain compliance with GMP regulations, internal quality systems, and established SOPs throughout all manufacturing and laboratory activities.
• Collect, analyze, and summarize production and laboratory data to support process monitoring, troubleshooting, and continuous improvement.
• Support inspection readiness activities and contribute to regulatory compliance efforts for FDA-regulated manufacturing operations.
• Perform environmental monitoring activities within the cleanroom and controlled areas to ensure ongoing compliance with environmental and biosecurity standards.
• Collaborate with cross-functional teams to support the transition from R&D to full GMP manufacturing and to drive ongoing operational improvements.
• Uphold biosecurity standards, including adherence to site-specific access and contact requirements related to swine exposure.

Essential Skills

• Bachelors degree in chemistry, biology, or a similar scientific discipline; an associates degree is acceptable with at least 3 years of relevant industry experience.
• Minimum of 1 year of experience working in a GMP-regulated environment.
• Minimum of 1 year of industry laboratory experience, preferably in manufacturing, bioprocessing, or related life sciences operations.
• Demonstrated proficiency in aseptic and sterile technique, verified through references or prior work experience.
• Strong writing skills, including the ability to produce clear, accurate, and compliant documentation, verified by references.
• Hands-on experience with laboratory procedures such as reagent preparation, sample handling, and data recording.
• Ability to follow detailed SOPs, adhere to Good Documentation Practices (GDP), and maintain meticulous records.
• Capability to operate and maintain laboratory and manufacturing equipment used in cell processing, encapsulation, microscopy, and cell counting.
• Commitment to working within biosecurity requirements, including avoiding residence on or near swine farms and refraining from routine contact with swine.

Additional Skills & Qualifications

• Experience in FDA-regulated manufacturing environments.
• Cleanroom or controlled environment experience, including familiarity with gowning procedures and cleanroom protocols.
• Background in cell-based therapies, bioprocessing, or pharmaceutical manufacturing.
• Strong attention to detail and ability to identify and report deviations or nonconformances.
• Comfort working with…