Environmental Monitoring and Sterility Assurance Manager

Andelyn Biosciences, Inc • Columbus, OH

1d • Onsite

About The Position

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.

Requirements

• Requires a bachelor’s degree in microbiology, Biology, Molecular Cellular Biology or related field
• Requires eight years of relevant experience in pharmaceutical environmental monitoring/microbiology
• Requires 3 to 5 years of experience in a leadership role
• Excellent knowledge of GMPs, FDA, EU and ISO standards/regulations
• Excellent knowledge of compendial procedures and guidance documents (i.e., USP, PIC/S, Annex 1)
• Experience in performing trend analysis
• Strong understanding of aseptic manufacturing, microbial environmental monitoring and Sterility Assurance
• Experience with quality event investigation is required
• Excellent communication and presentation skills
• Strong organizational and prioritization capabilities
• Skilled in technical writing and analytical problem-solving

Responsibilities

• 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 manufacturing, and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine operations
• Responsible for hiring, development, cultivate a diverse and collaborative team environment
• Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals
• Develop, implement, and drive continuous improvement initiatives within the Sterility Assurance and Environmental Monitoring program
• Frequent involvement and ultimate responsibility in audits and customer relations
• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products
• Demonstrate a high level of integrity and attention to detail in all job functions
• Maintain a positive attitude
• Exercise crucial people skills
• Other duties as assigned

Benefits

• Competitive compensation
• Eligible on 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager