GMP Scientist II (Suspension)

Contract position based in Columbus, OH.

About the role

The GMP Operations Scientist II guides all aspects of Good Manufacturing Practices (GMP) and production in the Clinical Manufacturing Facility (CMF). This role involves hands-on support and leadership for day-to-day GMP production operations, ensuring timely, compliant, and fiscally responsible delivery of biological products.

Responsibilities

• Solve, correct, and prevent problems while assigning tasks to junior staff.
• Work towards specific measurable objectives with minimal supervision.
• Lead and support a diverse and collaborative team, ensuring clear communication to achieve high productivity.
• Provide leadership in daily operational activities related to GMP manufacturing of biological products.
• Ensure availability of materials and proper documentation of GMP activities and product quality.
• Set and maintain professional standards within the GMP area.
• Support GMP resources and the supply chain, including ordering and maintaining materials inventory.
• Maintain accurate documentation on all GMP operations.
• Train and supervise junior staff to ensure proper operation of facility equipment and adherence to documentation standards.
• Guide operations staff in deviation investigations, OOS results, and process troubleshooting.
• Collaborate with GMP Management to identify and meet continuous improvement objectives.
• Incorporate new projects and technologies into the GMP area.
• Respond to alarm notifications from monitoring systems for laboratory temperature-controlled storage units.
• Operate within the Quality Management System and maintain compliance with regulatory requirements for cellular and gene therapy products.
• Demonstrate a high level of integrity and maintain a positive attitude.

Requirements

• Relevant four-year Life Science degree or Master's degree.
• Three years of relevant experience with a four-year degree or one year with a Master's degree.
• Background in life sciences, biotechnology, or gene therapy industries is ideal.
• Experience in a GMP or GLP setting.
• Excellent communication, organization, and project management skills.
• Proficiency in Microsoft Office (PowerPoint, Excel, Word), including data interpretation and reporting.
• Ability to work independently and collaboratively in a diverse work environment.

Skills

• Technical writing/SOP writing experience.
• Knowledge of GMP or bioprocessing.
• Experience in Suspension or Bioreactors.
• Experience in downstream processing, TFF, clarification, or large-scale cell culture.

Work Environment

The work culture is team-oriented, with a diverse and growing group. Collaboration is essential as tasks cannot be completed alone. The team is expanding from four members and aims to grow significantly by the end of the year. The dress code is business casual with appropriate lab attire. The shift is flexible, running from 7-8 AM to 5:30-6:30 PM, with adjustments as necessary to balance hours.

Pay

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.

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)