GMP Operations Scientist II — Biotech Manufacturing Lead

Actalent; Columbus (OH); On-site; USD 32,000 - 45,000; Full time

Job summary

Actalent is seeking a GMP Operations Scientist II to guide all GMP production activities in the CMF in Columbus, OH. The role combines hands-on support with leadership to ensure compliant, timely delivery of products in a contract-to-hire setting.

Ideal candidates have a life sciences background with GMP/GLP exposure, strong communication and project management skills, and the ability to lead a growing team in a fast-paced environment.

Qualifications

• Three years of relevant experience with a four-year degree or one year with a Master’s degree.
• Bg in life sciences, biotechnology, or gene therapy industries is ideal.
• Experience in a GMP or GLP setting.
• Proficiency in Microsoft Office, including data interpretation and reporting.

Responsibilities

• Solve, correct, and prevent problems while assigning tasks to junior staff.
• 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.

Skills

GMP/GLP experience

Life sciences degree

Leadership / supervising staff

Communication & project management

Microsoft Office (Excel/PowerPoint/WW)

Independent and collaborative work

Suspension or bioreactors experience

Education

Four-year Life Science degree or Master’s degree

Job description

Actalent is seeking a GMP Operations Scientist II to guide all GMP production activities in the CMF in Columbus, OH. The role combines hands-on support with leadership to ensure compliant, timely delivery of products in a contract-to-hire setting.

Ideal candidates have a life sciences background with GMP/GLP exposure, strong communication and project management skills, and the ability to lead a growing team in a fast-paced environment.