GMP Laboratory Technician

GMP Laboratory Technician

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Job Description

The GMP Laboratory Technician (GMP Operations Technician
1) supports all aspects of Good Manufacturing Practices (GMP) and production within a clinical manufacturing environment focused on cell-based manufacturing and viral vector core operations. This role provides hands-on support for day-to-day GMP production activities, including execution of manufacturing processes for biological products, accurate documentation, and facility and equipment maintenance. The technician helps ensure that all products are delivered in a timely, compliant, and cost-effective manner by following batch records and Standard Operating Procedures (SOPs) in a regulated environment.

Responsibilities

+ Support daily GMP manufacturing operations for biological products, including cell-based manufacturing in a controlled environment.

+ Execute production processes in accordance with approved batch records, SOPs, and GMP guidelines to ensure consistent product quality and compliance.

+ Provide hands-on assistance with viral vector core production operations and related clinical manufacturing activities.

+ Order and maintain materials inventory to support GMP resources and supply chain needs, ensuring adequate stock to meet production goals.

+ Ensure materials are available with appropriate documentation and traceability in alignment with GMP requirements.

+ Collaborate closely with GMP management and staff to identify and achieve continuous improvement objectives using metrics and other statistical tools.

+ Operate facility equipment and systems as specified in SOPs, including performing calibration, validation, and routine cleaning.

+ Assist in reviewing, revising, and remediating process documentation, including SOPs, batch records, and process change controls.

+ Support documentation activities by completing required records, logs, and forms accurately and in a timely manner.

+ Contribute to preparation activities for upcoming production steps, including organizing materials, documentation, and equipment.

+ Work in laboratory and cleanroom environments for the majority of the workday, adhering to aseptic techniques and gowning requirements.

+ Follow all safety, quality, and compliance standards while maintaining a clean, organized, and audit-ready work area.

+ Participate in training and cross-training to broaden technical capabilities and support team flexibility.

Essential Skills

+ Experience working in a GMP environment or aseptic processing setting.

+ BG in drug compounding, drug manufacturing, or food manufacturing under FDA or similar regulatory oversight.

+ 1-2 years of experience in the scientific industry preferred.

+ Foundational knowledge in biology, cell biology, microbiology, tissue culture, mammalian and eukaryotic cell culture, and laboratory practices.

+ Ability to follow detailed SOPs, batch records, and GMP documentation requirements with strong attention to detail.

+ Capability to operate, clean, calibrate, and support validation activities for laboratory and production equipment.

+ Comfort working in cleanroom environments and performing aseptic techniques.

+ Ability to occasionally lift, push, and pull 30-45 lbs as part of routine duties.

+ Strong interest and long-term desire to build a career in the science field.

+ Effective teamwork and communication skills to collaborate in a highly interactive, team-oriented environment.

Additional

Skills & Qualifications

+ Associate degree in Science preferred or equivalent education and experience in a related scientific discipline.

+

Experience with GMP documentation, including process change controls, documentation review, and remediation.

+ Familiarity with metrics and statistical methods to support continuous improvement initiatives.

+ Exposure to tissue culture, mammalian and eukaryotic cell culture techniques in a laboratory setting.

+ Ability to adapt to a growing, evolving organization and contribute in a start-up style environment.

+ Willingness to work a flexible schedule when needed to support production demands.

Work Environment

The work environment is a team-oriented, collaborative, and growing clinical manufacturing setting with a strong focus on GMP compliance and cell-based manufacturing. The team is diverse and continues to expand as operations scale, with significant opportunities for professional growth.…