GMP Scientist's

About the role

GMP Scientist I supports all aspects of Good Manufacturing Practices (GMP) and production within a clinical manufacturing environment. This role focuses on hands‑on cell‑based manufacturing in a GMP setting (not research) and involves executing production processes, maintaining accurate documentation, and supporting facility and equipment maintenance. The position plays a key role in delivering high‑quality biological products in a timely, compliant, and cost‑effective manner by following batch records and Standard Operating Procedures (SOPs). The role offers strong growth opportunities in a team‑oriented environment with access to a new, state‑of‑the‑art facility. This is a Contract‑to‑Hire position based in Columbus, OH.

Responsibilities

• Support all aspects of GMP operations and clinical manufacturing production activities for biological products.
• Execute day‑to‑day GMP and Viral Vector Core production operations, including hands‑on cell‑based manufacturing processes in a GMP environment.
• Follow batch records, Standard Operating Procedures (SOPs), and appropriate practices for manufacturing biological products to ensure compliance and product quality.
• Support GMP resources and the supply chain by ordering materials and maintaining inventory levels to meet production goals.
• Ensure the availability of materials with proper documentation that meets GMP requirements and supports manufacturing activities.
• Collaborate closely with GMP management to identify continuous improvement opportunities and help achieve objectives using metrics and other statistical tools.
• Operate facility equipment and systems according to SOPs, including performing calibration, validation, and routine cleaning.
• Assist with facility and equipment maintenance to ensure reliable and compliant operation.
• Support process documentation activities, including review, revision, remediation, and implementation of process change controls.
• 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.
• Adhere to aseptic techniques, clean room gowning procedures, and safety guidelines while working in controlled environments.
• Handle occasional lifting, pushing, and pulling of materials and equipment in the 30‑45 lb range as part of daily operations.

Requirements

• Experience working in a GMP environment or aseptic processing setting.
• Experience in drug compounding, drug manufacturing, or food manufacturing within an FDA‑regulated environment.
• Knowledge and understanding of aseptic technique and its application in cell‑based manufacturing.
• Understanding of liquid separation techniques relevant to biological manufacturing.
• Familiarity with laboratory practices in cell biology, microbiology, tissue culture, and related biological disciplines.
• Ability to follow detailed batch records, SOPs, and GMP documentation requirements with accuracy.
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