Associate Director, Quality Control Microbiology, Cell Therapy (R1544410-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
The primary focus of the QC Microbiology Associate Director role is to provide technical supervision and leadership of teams that are assigned to perform environmental monitoring, product release testing, routine and non-routine microbiological testing, at the BMS Jump facility in Bothell, WA. Role also includes collaborating with other departments to provide microbiology expertise and support for smooth running of GMP manufacturing operations.
Primary Responsibilities include:
Provide supervision of QC Microbiology Managers, Supervisors and Associates for the various shifts in the week
Oversee the day-to-day activities related to Environmental Monitoring, product release testing, and contamination control.
Implement, maintain, and oversee environmental monitoring, personnel monitoring, and utility monitoring
Oversee the EM trending program and analysis of EM/PM data Oversight of microbiology programs such as growth promotion, bioburden, BacT/ALERT rapid sterility, and endotoxin
Collaborate and oversee the execution of validation studies in support of facility validation projects such as EMPQ, cleanroom classification, APS and APQ
Provide technical assistance and guidance in areas of contamination control, disruptions in controlled classified environment and facility EM/PM trends
Assist in the transfer and implementation of microbiological test methods such as rapid sterility testing and endotoxin
Oversee equipment and instrument installation, operation and performance qualification
Author, review and execute SOPs, Protocols, Reports relating to GMP microbiology processes, test methods and related equipment maintenance Participate and support regulator audits
Perform other related duties and responsibilities as assigned
Minimum of 10 years working in a biopharmaceutical, cellular therapy, or gene therapy (commercial experience preferred)
Direct experience supporting the manufacturing, testing, disposition, and distribution of cGMP products, with a minimum of 5 years of prior managerial experience managing different shifts
Prior experience in participating in regulatory audits and supporting audit findings
Excellent technical writing, verbal, and written communication skills
Excellent collaboration, trouble shooting, and problem-solving skills
Strong team player that can also work independently to achieve goals and objectives
Strong project management skills and ability to own cross functional projects and bring them to completion within the set due date
Strong computer skills with Word and Excel; experience with e-Systems is preferred
Ability to work effectively in a fast-paced environment with cross functional departments, own multiple projects and meet the assigned timelines
Bachelor’s degree in a life science discipline. Masters or Ph.D. in Microbiology is preferred
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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