GMP Scientist II

INTERESTED CANDIDATES PLEASE REACH OUT TO CARRIE AT CSTUDEBA @ACTALENTSERVICES.COM OR TEXT 937. 903. 3402 TO SET UP A PHONE INTERVIEW! The GMP Operations Senior Scientist II leads and supports all aspects of Good Manufacturing Practices (GMP) and production within a Clinical Manufacturing Facility. This role provides hands-on leadership for day-to-day GMP production operations, oversees project timelines and personnel, and ensures the timely, compliant, and cost-effective manufacture of biological products, including cellular and gene therapy materials. The position combines technical expertise in mammalian suspension cell culture and bioprocessing with strong documentation, training, and continuous improvement responsibilities in a highly regulated environment.

Responsibilities

• Guide all aspects of GMP operations and production activities in the Clinical Manufacturing Facility, ensuring compliance with applicable regulatory requirements for cellular and gene therapy products.
• Lead and execute GMP manufacturing processes for biological products, including planning and coordinating production activities, ensuring the availability of materials, and maintaining accurate and complete documentation for all GMP activities.
• Manage project timelines and day-to-day operational priorities with minimal direct supervision, working to specific measurable objectives and adjusting plans as needed to meet production goals.
• Provide hands-on leadership to staff working in the manufacturing facility, including assigning tasks to junior team members and ensuring consistent adherence to batch records, Standard Operating Procedures (SOPs), and established practices.
• Set and maintain a professional standard within the GMP area, promoting a culture of integrity, accountability, and attention to detail in all job functions.
• Collaborate closely with GMP Management to enact the strategic direction of the GMP area and to identify, evaluate, and incorporate new projects and technologies into manufacturing operations.
• Support GMP resources and supply chain activities by ordering, tracking, and maintaining materials inventory to meet current and forecasted production needs.
• Maintain a high standard of accurate documentation on all GMP operations, ensuring that all activities are recorded according to SOPs and in alignment with the Quality Management System for phase-appropriate clinical material.
• Train and supervise junior staff in the proper operation of facility equipment, aseptic techniques, and the accurate documentation of GMP activities and product quality-related data.
• Work with GMP Management and Quality Assurance to guide Operations staff through deviation investigations, out-of-specification (OOS) results, and process troubleshooting, using metrics and other statistical tools to drive continuous improvement.
• Collaborate with GMP Management to define and meet continuous improvement objectives, leveraging data and performance metrics to enhance efficiency, quality, and compliance.
• Respond to and take appropriate action based on alarm notifications from monitoring systems for laboratory temperature-controlled storage units during assigned periods of responsibility.
• Operate in alignment with established policies, procedures, and techniques, applying relevant training, practical experience, and working knowledge of GMP tasks to daily operations.
• Exercise discretion, judgment, and personal responsibility in all aspects of work, demonstrating a high level of integrity and maintaining a positive, solutions-oriented attitude.
• Lead and support a diverse and collaborative team environment by using clear, concise communication to drive high productivity and meaningful contributions to team goals.
• Ensure that all activities performed in the GMP area are fully documented according to SOPs and regulatory expectations, supporting audit readiness and data integrity.

Essential Skills

• Relevant four-year Life Science degree or Masters degree (e.g., biology, biotechnology, or related discipline).
• Minimum of 3 years of relevant experience with a four-year degree or 1 year of relevant experience with a Masters degree.
• Background in life sciences, biotechnology, or gene therapy industries preferred.
• Prior experience in a GMP or GLP setting strongly preferred, with working knowledge of GMP principles and bioprocessing operations.
• Strong technical skills in mammalian cell culture, including suspension culture, tissue culture, and eukaryotic cell handling.
• Proficiency with aseptic technique and microbiology concepts applicable to cell-based manufacturing and testing.
• Experience with cell-based assay development and related analytical methods.
• Excellent communication skills, with the ability to convey technical information clearly and collaborate effectively across diverse teams.
• Strong organizational and project management skills, with the ability to manage multiple projects efficiently and adapt to changing priorities.
• High proficiency in Microsoft Office applications (PowerPoint, Excel, Word), including data interpretation, analysis, and reporting.
• Ability to work independently with minimal supervision as well as collaboratively in a diverse and inclusive team environment.
• Demonstrated attention to detail and commitment to accurate documentation in all aspects of GMP operations.
• Ability to operate within a Quality Management System and maintain compliance with regulatory requirements for cellular and gene therapy products.

Additional Skills & Qualifications

• Technical writing experience, including drafting and revising SOPs, is preferred.
• Knowledge of GMP manufacturing and bioprocessing, including upstream and downstream operations.
• Prior experience with suspension cell culture and bioreactors is a significant plus.
• Experience with downstream processing such as tangential flow filtration (TFF), clarification, or large-scale cell culture is strongly preferred.
• Familiarity with metrics and statistical tools used to monitor process performance and drive continuous improvement.
• Demonstrated ability to lead and support a collaborative team environment, fostering clear communication and high productivity.

Work Environment The work environment is highly team-oriented and collaborative, with a diverse group of professionals who are continuing to grow alongside an expanding cell and gene therapy manufacturing operation. The immediate team is currently small and expected to grow significantly, and all work and testing activities are performed in close coordination with colleagues rather than independently. The role is based in a modern clinical manufacturing facility that emphasizes GMP compliance, quality, and safety in the handling of biological materials. Business casual attire is appropriate, complemented by required laboratory attire when working in GMP and lab areas. The typical work schedule follows a four-day pattern, generally from approximately 7:008:00 a.m. to 5:306:30 p.m., and requires flexibility to work later on some days, with start times adjusted when possible to balance weekly hours. The culture values integrity, positive attitudes, clear communication, and mutual support, offering opportunities to contribute directly to cutting-edge cell and gene therapy manufacturing in a fast-growing organization.

Job Type & Location This is a Contract to Hire position based out of Columbus, OH.

Pay And Benefits The pay range for this position is $28.00 - $28.00/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.

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 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)

Job Type & Location This is a Contract to Hire position based out of Columbus, OH.

Application Deadline This position is anticipated to close on Nov 6, 2026.

Workplace Type This is a fully onsite position in Columbus,OH.

About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.