GMP Scientist

GMP Scientist I / GMP Operations Technician I

The GMP Scientist I / GMP Operations Technician I supports all aspects of Good Manufacturing Practices (GMP) and production within a clinical manufacturing environment focused on cell-based manufacturing. This role provides hands-on support for day-to-day GMP and viral vector core production operations, including execution of production processes, documentation, and facility and equipment maintenance. The position contributes directly to the timely, compliant, and cost-effective delivery of biological products by following established batch records and Standard Operating Procedures (SOPs).

This is a non-research role that operates primarily in a GMP laboratory and clean-room setting.

• Support all aspects of GMP operations and production in a clinical manufacturing facility focused on cell-based manufacturing.
• Execute production processes for biological products in accordance with batch records, Standard Operating Procedures (SOPs), and GMP guidelines.
• Provide hands-on assistance for day-to-day GMP and viral vector core production operations, ensuring activities are completed accurately and on schedule.
• Order, receive, and maintain materials and consumables to support production goals, ensuring appropriate documentation and traceability for GMP activities.
• Monitor and manage inventory of GMP resources and supplies to ensure continuous availability of materials required for manufacturing.
• Support daily operational activities related to GMP manufacturing by verifying that materials meet quality requirements and are accompanied by proper documentation.
• Work closely with GMP management to identify continuous improvement opportunities using metrics and other statistical tools, and help implement process enhancements.
• Operate facility equipment and systems in accordance with SOPs, including routine use during production activities.
• Perform calibration, validation, and cleaning of facility equipment and systems as specified in SOPs to maintain a qualified and compliant state.
• Assist in the review, revision, and remediation of process documentation, including batch records and SOPs, to ensure accuracy and regulatory compliance.
• Support process change control activities by documenting proposed changes, contributing to impact assessments, and following approved implementation procedures.
• Spend approximately 5075% of work time in the laboratory and clean room performing hands-on production and operational tasks.
• Spend approximately 25% of work time on documentation, paperwork, and preparation for upcoming production steps.
• Adhere strictly to aseptic techniques and GMP standards to maintain product quality and prevent contamination.
• Follow all safety, quality, and compliance procedures while working in laboratory and clean room environments.
• Occasionally lift, push, or pull materials and equipment weighing approximately 3045 pounds as part of routine operational duties.

• Experience working in aseptic processing or GMP manufacturing environments.
• Experience in drug compounding, drug manufacturing, food manufacturing, or other FDA- regulated production settings.
• 23 years of experience in the scientific industry preferred.
• Knowledge and understanding of aseptic technique and its application in GMP manufacturing.
• Knowledge of cell culture techniques, including mammalian or eukaryotic cell culture.
• Understanding of liquid separation techniques relevant to biological manufacturing processes.
• Familiarity with tissue culture and microbiology laboratory practices.
• Ability to work effectively in laboratory and clean room environments for extended periods.
• Ability to occasionally lift, push, or pull 3045 pounds in support of production and facility operations.
• Strong attention to detail and adherence to documented procedures and SOPs.
• Demonstrated long-term interest and desire to build a career in the science field.

• Associate or Bachelors degree in a science-related discipline preferred.
• Prior cell-based experience with mammalian or eukaryotic cells is a strong plus.
• Experience in laboratory environments involving GMP, tissue culture, cell biology, and microbiology.
• Comfort working in a highly regulated, documentation-driven environment.
• Ability to collaborate with GMP management and cross-functional teams to support continuous improvement initiatives.
• Strong organizational skills for managing inventory, materials, and documentation.
• Team-oriented mindset and…