GMP Operations Leader — Gene Therapy Manufacturing

Andelyn-Biosciences; Columbus (OH); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

Holidays

Life Insurance

401(k) Match

Disability Insurance

Parental Leave

Tuition Reimbursement

LinkedIn Learning

Employee Assistance Program

Flexible work options

Job summary

Andelyn Biosciences in Columbus, OH, is seeking a GMP Operations Senior Scientist to lead all GMP production activities in the Clinical Manufacturing Facility (CMF). You will provide hands-on leadership, training, and supervision, ensuring compliant, timely manufacturing and documentation while partnering with GMP Management on improvements and strategic direction.

You will mentor staff, manage projects, and maintain strict adherence to SOPs and regulatory requirements for cellular and gene

Qualifications

• Must possess a relevant four-year degree, OR a relevant master’s, OR a relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred.
• Five years relevant (w/4 YR deg) OR two years (w/Masters).
• Experience in biologics or gene therapy preferred.
• Experience in a highly regulated field preferred.
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
• Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word), including data interpretation and reporting.
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
• Must possess a client-focused mindset in daily tasks.
• Must possess prior experience handling confidential information and the ability to maintain confidentiality.

Responsibilities

• Lead and supervise GMP production operations in the CMF.
• Provide hands-on support and leadership for day-to-day GMP production activities.
• Train staff and ensure proper documentation and SOP adherence.
• Collaborate with GMP Management to guide strategic direction and continuous improvement.
• Ensure compliance with regulatory requirements for cellular and gene therapy products.

Job description

Andelyn Biosciences in Columbus, OH, is seeking a GMP Operations Senior Scientist to lead all GMP production activities in the Clinical Manufacturing Facility (CMF). You will provide hands-on leadership, training, and supervision, ensuring compliant, timely manufacturing and documentation while partnering with GMP Management on improvements and strategic direction.

You will mentor staff, manage projects, and maintain strict adherence to SOPs and regulatory requirements for cellular and gene