Sterility Assurance Supervisor

Andelyn Biosciences is a biopharmaceutical CDMO that specializes in advancing novel gene therapies from concept to commercialization. Located in Columbus, OH , the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities. Employees are expected to perform the following essential functions under the framework of our ACCTS actions. Supervisor of Sterility Assurance The Supervisor of Sterility Assurance will be responsible for quality assurance oversight of aseptic processing programs, contamination control strategy, and microbial control policies for Operations. This individual should be able to work independently with little direction to develop and implement policies and procedures and related completed media fill/APS documentation, cleanroom qualifications, environmental excursions SME, deviations and sterility failures. This will include contamination analysis, development of contamination control plans across numerous programs from unit level up to integration and test, coordination of contamination control design across the in‑house team and subcontracts. Provide strategic plan and expertise for the development and implementation of the site Sterility Assurance Program. Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release. Develop and Lead Sterility Assurance Council. Provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements. Assess facility and quality systems’ state of compliance with internal requirements and appropriate regulations and participate in the development of action plans to correct deficiencies and improve quality processes. Provide expertise to support environmental excursions, deviations, CAPAs and complaints related to aseptic processing. Demonstrated experience writing contamination control plans and implementation. Working knowledge of the manufacture of advanced therapies medicinal products. Working knowledge of FDA and EMA requirements as they pertain to contamination control. Hands‑on experience in contamination control. Understanding of principles and methods for contamination control in cleanroom environments. Knowledge and experience with Grade A to Grade D Cleanrooms. Ability to provide concurrent support to multiple programs. Familiarity with ISO cleanroom requirements and methods of operation. Prepare project plans, write status reports, and give oral presentations to customers and management. Other duties as assigned. What you bring to the team Four‑year degree, or relevant Masters or Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred. Prior experience in contamination control/sterility assurance. Broad knowledge of the field with proven leadership skills. Prior management experience required. 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. What you can expect when working at Andelyn The pride of contributing to the development and manufacturing of life‑saving therapies. The invaluable experience of being part of building the foundation of a new organization. Opportunity to work alongside experts with over 10 years in the gene therapy field. Competitive compensation. Eligible day one for medical, dental, and vision insurance plans with basic vision at 100% company‑paid. 160 hours of Paid Time Off annually. 11 Company Paid Holidays plus 2 floating holidays annually. Company Paid Life Insurance. 401(k) Match. Company Paid short and long‑term disability. 4 weeks of Paid Parental Leave for birth and adoption. Adoption Assistance. Tuition Reimbursement and Student Loan Repayment Assistance. Company Paid LinkedIn Learning access. Employee Assistance Programs. Flexible work options (role specific). Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone feels included. #J-18808-Ljbffr Valid8 Financial, Inc.