Job Details
Quality
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
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 direct experience in biologics, cell therapy or sterile drug product microbial contamination control and 5+ years of increasing management responsibility.
Expert knowledge of common QC and environmental/clean utility monitoring procedures, techniques, and laboratory equipment/instrumentation, and the application and interpretation of GMP concepts and compendia requirements (e.g., USP, CFR).Advanced proficiency in microbiological assay methodologies including, sterility, container closure integrity, microbial identification and rapid microbiological techniques and technologies.
Experience in manufacturing facility startup is highly desirable.
Knowledge of cell therapy or biologics manufacturing is highly desirable.
Expert knowledge of US and EU cGMP regulations and guidance. Extensive and proven experience in FDA (or other regulatory authority) inspection preparation and management is essential.
Self-directed with a high degree of professional integrity, highly organized and detail oriented. Ability to work independently and to collaborate cross functionally to drive operational and quality excellence.
Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.
Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.
Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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