GMP Scientist I

Actalent; Kentucky; On-site; USD 55,000 - 75,000; Full time

Job summary

Actalent in Kentucky is seeking a GMP Scientist I / GMP Operations Technician I to support cell-based manufacturing in a Clinical Manufacturing facility. You will execute production processes, document batch records, and maintain GMP-compliant operations.

This role emphasizes hands-on lab work 50–75% of the time and documentation 25%, with focus on aseptic technique, SOP adherence, and collaboration with GMP leadership to ensure timely, compliant biotech production.

Qualifications

• Experience in aseptic processing or GMP manufacturing.
• Background in drug compounding, drug manufacturing, or FDA-regulated industry.
• 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.

Responsibilities

• 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.

Skills

Aseptic GMP

FDA-regulated manufacturing

Experience 2-3 yrs

Aseptic technique

Cell culture

Biology basics

Equipment operation

Teamwork & communication

Education

Associate's degree in a scientific discipline

Job description

Job Description

Job Title: GMP Scientist I / GMP Operations Technician I

Job Description

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.

Responsibilities

• 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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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 environment within a larger supported organization.
• Willingness to work primarily in a non-research, production-focused role.

Work Environment

The work environment is a highly collaborative, team-oriented Clinical Manufacturing facility with a diverse group of professionals who are cont