GMP Laboratory Technician

GMP Laboratory Technician

The GMP Laboratory Technician is responsible for supporting all aspects of Good Manufacturing Practices (GMP) and production within a clinical manufacturing environment. This role provides hands-on assistance with day-to-day GMP and viral vector core production operations, including execution of production processes, accurate documentation, and facility and equipment maintenance. The technician helps ensure that biological products are manufactured in a timely, compliant, and fiscally responsible manner by following established practices, batch records, and Standard Operating Procedures (SOPs).

Approximately 50–75% of the role involves working in the laboratory and clean room, with the remaining time focused on documentation and preparing for subsequent steps in the manufacturing process. This is a cell-based manufacturing position in a GMP environment and is not research-based.

Responsibilities

• Support GMP operations and production activities for clinical manufacturing of biological products.
• Execute cell-based manufacturing processes in a GMP environment, following batch records and SOPs.
• Maintain accurate and complete documentation for all GMP activities, including production records and process logs.
• Order and maintain materials inventory to ensure adequate GMP resources and supplies to meet production goals.
• Assure the availability of materials with proper documentation and traceability required for GMP manufacturing.
• Work closely with GMP management to identify and achieve continuous improvement objectives using metrics and other statistical tools.
• Operate facility equipment and systems in accordance with SOPs, ensuring proper use and safety.
• Perform calibration, validation, and cleaning of facility equipment and systems as specified in SOPs.
• Assist in the review, revision, and remediation of process documentation to maintain compliance and accuracy.
• Support process change controls by helping to document and implement approved changes to manufacturing procedures.
• Contribute to day-to-day viral vector core production operations and related manufacturing tasks.
• Prepare materials, equipment, and documentation for upcoming manufacturing runs and process steps.
• Work in laboratory and clean room environments for the majority of the workday, adhering to all gowning and aseptic procedures.
• Handle occasional lifting, pushing, and pulling of materials and equipment weighing approximately 30–45 pounds.
• Collaborate with a diverse, team-oriented group to meet production timelines and quality standards.

Essential Skills

• Experience working in aseptic processing or GMP manufacturing environments.
• Bg in drug compounding, drug manufacturing, or food manufacturing regulated by the FDA.
• 1–2 years of experience in the scientific industry preferred.
• Foundational knowledge of biology, cell biology, and microbiology.
• Experience with tissue culture and cell culture, including mammalian and eukaryotic cell systems.
• Ability to work effectively in a laboratory setting and clean room environment.
• Capability to follow detailed SOPs, batch records, and GMP documentation requirements.
• Comfort with occasionally lifting, pushing, and pulling 30–45 pounds.
• Strong interest in and long-term commitment to working in the science field.
• Attention to detail and accuracy in documentation and process execution.
• Ability to collaborate in a team-oriented environment and communicate clearly with colleagues and management.

Additional Skills & Qualifications

• Associate's degree in a science-related field preferred.
• Experience in GMP manufacturing of biological products is highly beneficial.
• Familiarity with laboratory operations involving tissue, mammalian, and eukaryotic cell culture.
• Understanding of viral vector core production processes is a plus.
• Comfort working on feet for most of the day in a laboratory and clean room setting.
• Ability to adapt to a growing, start-up-like environment with strong institutional backing.
• Interest in professional growth and development within a state-of-the-art manufacturing facility.

Work Environment

The work environment is highly team-oriented and collaborative, with a diverse group of professionals who…