It’s an exciting time to join us!
Andelyn Biosciences’ is seeking a motivated individual to join our growing team as Cleanroom Microbiology and Environmental Monitoring Manager.
The Cleanroom Microbiology and Environmental Monitoring 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, and execution of critical cleanroom contamination control strategies. 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), oversight of project timelines/tasks, approval of technical and procedural documents, as well training and mentoring junior staff. The Manager will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion.
Schedule: Full-time (Benefits Eligible)
Location: Central Campus
575 Children's Crossroads
Columbus, OH 43205
Under the guidance and direction of Facilities and Contamination Control/Clinical Manufacturing, essential functions of the Cleanroom Microbiology and Environmental Monitoring Manager include at a minimum:
· 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 of EM sampling scheduling to support manufacturing, meet project timelines, and ensure compliance with policies and procedures
· Participate in cross-functional quality event investigations related to EM excursions / adverse trends
· Analyze data summaries and perform statistical evaluations for quarterly EM trending reporting
· Identifies and initiates investigations of adverse EM trends
· Present quarterly EM trending findings to Andelyn Quality Council and Contamination Control Committee
· Regularly monitor applicable information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine operations
· Anticipating problems and removing obstacles to enable staff to perform tasks as assigned
· Have significant latitude for making decisions for the operational/functional unit
· Managing and influencing people indirect or lateral reporting structure
· Responsible for hiring, development, and related personnel processes
· Has budgetary responsibility
· Cultivate a diverse and collaborative team environment
· Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals
· Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
· 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
· Attention to detail in all job functions
· Maintain a positive attitude
· Exercise crucial people skills
· Other duties as assigned
Knowledge, Skills, and Abilities required:
· Requires a relevant four-year degree with at least eight years of relevant experience in pharmaceutical environmental monitoring/microbiology
· Excellent knowledge of GMPs, FDA, and EU regulations
· Knowledge of compendial procedures and guidance documents (i.e. USP)
· Experience in performing trend analysis
· Has in-depth working knowledge and understanding of microbial environmental monitoring – basic understanding of non-viable particulate monitoring is desired
· Experience with quality event investigation is required
· Experience with microbiology in aseptic manufacturing cleanroom environments preferred
· Prior supervisory experience is highly preferred
Minimum Physical Requirements
· There are very minimal physical requirements. One needs to be able to lift 20-30 pounds occasionally (0-33% of the time).
· May require ability to aseptically gown or wear other PPE on regular basis.
· Must be able to stand for extended periods.
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned. It is not to be construed as an exhaustive list of duties performed by the individual so find, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.
Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated