Sterility Assurance Supervisor

Andelyn Biosciences - Columbus, OH

Full-time - Mid Level

Columbus, OH

101-250 employees

Ambulatory Health Care Services

About the position

The Sterility Assurance Supervisor at Andelyn Biosciences is responsible for overseeing quality assurance in aseptic processing programs, ensuring compliance with contamination control strategies and microbial control policies. This role involves developing and implementing policies, managing contamination control plans, and providing expertise to operations to meet both US and international aseptic processing requirements. The supervisor will also lead the Sterility Assurance Council and assess facility compliance with internal and regulatory standards.

Responsibilities

• Oversee quality assurance of aseptic processing programs and contamination control strategies.
• Develop and implement policies and procedures related to sterility assurance.
• Manage completed media fill/APS documentation and cleanroom qualifications.
• Conduct contamination analysis and develop contamination control plans.
• Provide strategic planning and expertise for the Sterility Assurance Program.
• Ensure aseptic processing meets US and international requirements.
• Assess compliance of facility and quality systems with internal and regulatory standards.
• Support environmental excursions, deviations, CAPAs, and complaints related to aseptic processing.
• Prepare project plans, status reports, and presentations to management and customers.

Requirements

• Four-year degree or relevant Master's or Ph.D. in life sciences, biotechnology, or gene therapy industries.
• Prior experience in contamination control and sterility assurance.
• Broad knowledge of the field with proven leadership skills.
• Prior management experience is required.
• Excellent communication, organization, and project management skills.
• Ability to manage multiple projects efficiently and adjust priorities as needed.
• Proficiency in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
• Ability to work independently and collaboratively in a diverse environment.
• Experience handling confidential information.

Nice-to-haves

• Experience in the manufacture of advanced therapies and medicinal products.
• Familiarity with FDA and EMA requirements for contamination control.
• Knowledge of ISO cleanroom requirements and methods of operation.

Benefits

• 401(k) matching
• Adoption assistance
• Dental insurance
• Disability insurance
• Employee assistance program
• Life insurance
• Loan assistance
• Medical, dental, and vision insurance plans
• 160 hours of Paid Time Off annually
• 11 Company Paid Holidays plus 2 floating holidays annually
• Company Paid short and long-term disability
• 4 weeks of Paid Parental Leave for birth and adoption
• Tuition Reimbursement and Student Loan Repayment Assistance
• Company Paid LinkedIn Learning access
• Flexible work options (role specific)