GMP Scientist I

Job Title:

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 facility. In close collaboration with GMP Operations leadership and production staff, this role provides hands‑on support for day‑to‑day GMP and Viral Vector Core manufacturing activities, including execution of production processes, documentation, and facility and equipment maintenance. The position focuses on cell-based manufacturing in a GMP environment, ensuring that all biological products are produced in a timely, compliant, and cost‑effective manner by following batch records and Standard Operating Procedures (SOPs).

This is not a research‑based role and is ideal for individuals who want to build a long‑term career in the scientific and manufacturing field.

• Support all aspects of GMP operations and production in the Clinical Manufacturing facility, with a focus on cell-based manufacturing.
• Execute GMP and Viral Vector Core production processes according to approved batch records and Standard Operating Procedures (SOPs).
• Assist with day‑to‑day manufacturing activities to ensure timely, compliant, and fiscally responsible delivery of biological products.
• Support GMP resources and the supply chain by ordering materials and maintaining inventory to meet production goals.
• Ensure the availability of materials with proper documentation and traceability in alignment with GMP requirements.
• Work closely with GMP management to identify continuous improvement opportunities and help achieve 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 the review, revision, and remediation of process documentation, including batch records and SOPs.
• Support process change controls by documenting changes accurately and maintaining compliance with GMP standards.
• Spend approximately 50–75% of time working in the laboratory and clean room performing hands‑on production activities.
• Spend approximately 25% of time supporting documentation, paperwork, and preparation for upcoming process steps.
• Follow aseptic techniques and clean room procedures to maintain a controlled and compliant manufacturing environment.
• Handle and move materials and equipment safely, including occasionally lifting, pushing, or pulling 30–45 pounds.
• Collaborate effectively with a diverse, team‑oriented group to support a growing, start‑up‑phase operation within a state‑of‑the‑art facility.

• Experience working in an aseptic processing or GMP manufacturing environment.
• Background in drug compounding, drug manufacturing, or food manufacturing regulated by the FDA.
• 2–3 years of experience in the scientific industry preferred.
• Knowledge and understanding of aseptic technique and clean room practices.
• Experience or familiarity with cell culture, including mammalian or eukaryotic cell‑based processes.
• Understanding of liquid separation techniques relevant to biological manufacturing.
• Foundational knowledge in biology, microbiology, tissue culture, and cell biology.
• Ability to operate laboratory and production equipment in accordance with SOPs.
• Comfort with occasionally lifting, pushing, or pulling 30–45 pounds as part of routine duties.
• Strong attention to detail and commitment to following GMP documentation and procedures.
• Long‑term interest and desire to build a career in the science and manufacturing field.
• Effective teamwork and communication skills in a collaborative production environment.

• Associate’s degree in a scientific discipline preferred.
• Prior hands‑on experience with mammalian or eukaryotic cell culture is a strong plus.
• Experience working in tissue culture or cell‑based laboratory environments.
• Exposure to laboratory operations involving microbiology, tissue biology, or related fields.
• Ability to support continuous improvement initiatives using metrics and basic statistical methods.
• Comfort working in a fast‑growing, start‑up‑phase…