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.

About the role

This 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.

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.
• 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.

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 and routinely gown up to enter clean rooms, following strict aseptic and contamination control procedures.

The position operates on a Monday through Friday schedule from 8:00 a.m. to 5:00 p.m. The dress code consists of casual lab attire, including closed-toe shoes, socks covering the ankles, khaki pants or jeans without holes, and shirts without large graphics, with additional clean room gowning required when working in controlled environments.

Schedule

Monday through Friday, 8:00 a.m. to 5:00 p.m.

Pay

The pay range for this position is $24.00 - $24.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Location

This is a fully onsite, Contract to Hire position based in Columbus, OH.