Urgently Hiring: GMP Laboratory Technician

Position: URGENTLY HIRING: 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. Approximately 50-75% of the time is spent working in the laboratory and clean rooms, performing hands-on manufacturing and technical activities, while about 25% of the time is dedicated to documentation, preparation, and support tasks.

The role requires being on your feet for most of the day and regularly gowning up to enter and work in clean rooms. The facility is transitioning into a new, state-of-the-art site while retaining a start-up phase atmosphere, supported by a well-established…