Environmental Monitoring and Sterility Assurance Manager

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (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.

The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality through our ACCTS
ions.

ACCOUNTABLE in our actions.

COM PASSIONATE in our thinking.

TRUST WORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTS
ions.

The Environmental Monitoring and Sterility Assurance Manager will complete the principal duties and responsibilities outlined below. Working in collaboration with leadership and senior staff, the Manager will plan and oversee the development, implementation, execution of critical cleanroom sterility assurance strategies, aseptic processing programs, contamination control strategy, and microbial control policies for Operations. Activities may include oversight of routine environmental monitoring (EM) program, approval of EM trending reports, investigation of quality events, development, and management of corrective action / preventative action (CAPA), media fill/APS documentation, cleanroom qualifications, deviations and sterility failures, oversight of project timelines/tasks, approval of technical and procedural documents, as well training and mentoring junior staff.

This will include contamination analysis, development of contamination control plans across numerous programs from unit level up to integration and test, and coordination of contamination control design. The Manager will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion.

• Developing and enforcing procedures and controls related to environmental monitoring and associated reporting and trending practices – may include, but is not limited to, standard operating procedures, work instructions, technical protocols, technical reports
• Responsibility for EM sampling scheduling to support manufacturing, meet project timelines and ensure compliance with policies and procedures
• 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
• Oversee, Manage and support the execution of the contamination control strategy for the facility including, but not limited to aseptic process validation, facility design and modification, gowning, critical utilities, and EMPQs
• Generates, owns, and/or supports change controls, deviations, CAPAs within the eQMS system.
• Identify, review and approve an investigation of adverse EM Excursions/trends and participate in cross-functional quality event investigations
• Analyze data summaries and perform statistical evaluations for quarterly EM trending reporting
• Develop and Lead Sterility Assurance Council. Present quarterly EM trending findings to Andelyn Quality Council and Contamination Control Committee
• Prepares project plans, writes status reports, and gives oral presentations to customers and management
• Regularly monitor applicable information published by the US FDA, EMA, PIC/S, Annex 1, pharmaceutical…