GMP Senior Scientist: Gene Therapy Manufacturing Lead

Andelyn Biosciences; Columbus (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, dental & vision insurance (on

401(k) match

Paid time off

Job summary

Andelyn Biosciences in Columbus, OH, seeks a GMP Senior Scientist to lead production within a cGMP clean room. You will coordinate with leadership, supervise staff, and ensure training, documentation and regulatory compliance for timely client deliverables.

Ideal candidates bring strong cGMP knowledge, leadership, and project management skills, with a track record of coaching teams to maintain quality and safety in viral vector/plasmid manufacturing.

Qualifications

• Bachelor's or higher in life sciences or related field.
• Strong knowledge of cGMP, GLP and FDA guidelines.
• Excellent communication, organization and project management skills.
• Ability to lead, mentor and develop Operations staff.

Responsibilities

• Lead production activities in a cGMP clean room environment.
• Collaborate with Operations Leadership on daily priorities and staffing.
• Ensure training, documentation, regulatory and fiscal compliance.
• Manage change requests and CAPAs for process improvements.
• Engage with QA to investigate deviations and ensure product quality.

Skills

Leadership

Communication

Project management

Regulatory compliance

Attention to detail

Team coordination

Education

Bachelor's degree in life sciences

Master's degree in life sciences

PhD in life sciences

Tools

Microsoft Office

Job description

Andelyn Biosciences in Columbus, OH, seeks a GMP Senior Scientist to lead production within a cGMP clean room. You will coordinate with leadership, supervise staff, and ensure training, documentation and regulatory compliance for timely client deliverables.

Ideal candidates bring strong cGMP knowledge, leadership, and project management skills, with a track record of coaching teams to maintain quality and safety in viral vector/plasmid manufacturing.