GMP Scientist

GMP Scientist I

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.

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.

Essential Skills

• 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.
• Comfort working in a clean room environment and adhering to gowning and contamination control procedures.
• Ability to occasionally lift, push, and pull 30–45 lbs as part of routine duties.
• Demonstrated long-term interest and desire to build a career in the science field.

Additional Skills & Qualifications

• 2–3 years of experience in the scientific industry in a GMP setting.
• Prior hands-on experience with mammalian or eukaryotic cell culture is a strong plus.
• Experience working in regulated environments such as drug manufacturing or food manufacturing is advantageous.
• Strong teamwork, communication, and collaboration skills in a diverse and growing group.
• Interest in continuous learning and contributing to process improvements in a GMP setting.

Work Environment

The work environment is a team-oriented, collaborative, and diverse setting within a clinical manufacturing facility that is growing and transitioning into a new, state-of-the-art site. The role is primarily on-site, with approximately 50–75% of the time spent in the laboratory and clean rooms performing hands-on GMP manufacturing activities and about 25% dedicated to documentation and preparation tasks. Team members spend most of the day on their feet…