Associate Director, Sterility Assurance

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Position Summary

The Associate Director, Sterility Assurance, is a key leader and a champion for microbial control principles and compliance within site.  This role will be responsible to provide leadership and quality oversight in the design, implementation and continuous improvement of the systems and processes in support of the development and maintenance of the Devens CTF contamination prevention program.  This leader also provides technical expertise and quality oversight in the areas of endotoxin, mycoplasma, sterility, environmental monitoring and utility testing conducted for the site. This function plays a critical role in supporting health authority inspections, facility design/modifications, cleaning and sanitization program and studies, aseptic process validation program, operator qualification/requalification, introduction and validation of new technologies/methods, microbiology related investigations, and the gowning certification/recertification program. Additionally, this role leads the Devens CTF Environmental Action Committee and drives the Environmental Monitoring trending program. This role will directly interface with internal and external stakeholders to deliver exceptional results and drive continuous improvement of the microbial control systems and processes used at the site. 

Key Responsibilities

• Provide expert level of applied knowledge and in-depth understanding of microbiological techniques including sterility, endotoxin, mycoplasma, environmental monitoring, identification of organisms and contamination control strategies.

• Provide technical leadership and expertise for microbial contamination control and support the Aseptic Operations program. Act as Devens primary point of contact/key contributor for contamination control program network initiatives. Lead evaluation and implementation of new technologies/methods.

• Lead risk assessments for contamination control programs. 

• Owner of the Devens CTF Environmental Action Committee (EAC) for the review and performance of the facility environmental controls program.

• Drive Environmental Monitoring trending program, providing oversight of trending data compilation, review, and reporting.  Approve trending investigations.

• Support completion of Annual Product Quality Review and periodic investigation trending reports.

• Participate in the site team which prepares for, hosts, and responds to regulatory inspections, internal audits, and reviews/approvals of the facility and products.

• Act as SME in front room and responsible for backroom document/briefing package review and development.

• Establish, implement, and sustain appropriate microbial control training programs in collaboration with training leads.

• Drive harmonization of policies, practices, and procedures across BMS CAR-T sites globally. Verify compliance with applicable BMS Policies and Procedures and ensure consistency with other site procedures and/or specifications.

• Participate in external forums to remain current with industry trends to ensure procedures, policies and practices remain current.

• Create, review and/or approve microbiological studies, procedures, test methods, protocols, reports and other documentation related to microbial control.

• Provide quality oversight of sterility assurance related validation activities, such as Aseptic Process Simulation and Environmental Monitoring Performance Qualification

Qualifications & Experience

• A minimum of 10 years with a BS in Microbiology, Biology, or related field with