Bristol Myers Squibb Site Microbiologist Cell Therapy in Devens, Massachusetts
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.
Bristol Myers Squibb is seeking a Site Microbiologist at the Cell Therapy Facility (CTF) in Devens, MA. This role will be responsible to provide leadership within the QC Microbiology organization 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. The Site Microbiologist will provide technical expertise in the area of endotoxin, sterility or environmental monitoring and utility testing conducted for the Devens CTF. The Site Microbiologist also plays a critical role in supporting facility design/modifications, cleaning and sanitization, the aseptic process validation (APV) program, operator qualification/requalification, introduction and validation of new technologies/methods, method transfers, microbiology related investigations, and the gowning certification/recertification program.
The Site Microbiologist role is stationed in Devens, MA and reports to the Head of QC Microbiology for the Devens Cell Therapy Facility.
Provide expert level of applied knowledge and in-depth understanding of microbiological techniques including sterility, endotoxin, environmental monitoring, identification of organisms and contamination control strategies.
Provide technical leadership and expertise for QC Microbiology studies and projects.
Lead and conduct risk assessments for aseptic operations and contamination control.
Evaluation and implementation of new technologies/methods
Establishing and implementing appropriate training programs in collaboration with training leads
Harmonization of policies, practices, and procedures across CAR T sites globally
Participation in external forums to remain current with industry trends to ensure procedures, policies, and practices remain current
Create, review and approve microbiological studies, procedures, test methods, protocols, reports and other documentation related to QC Microbiology testing.
Provide training to QC Microbiology staff to assure testing activities occur in an efficient and cGMP compliant manner.
Perform efficient and timely technology transfer of QC Microbiology test methods.
Provide expertise in projects (e.g., Lean Labs) related towards the goal of continuous improvement.
Support completion of Annual Product Quality Review and periodic investigation trending reports.
Verify compliance with applicable BMS Policies and Procedures and ensure consistency with other site procedures and/or specifications.
Qualifications and Education Requirements
A minimum of 15 years with a BS in Microbiology, Biology or related field or 10 years with a MS in Microbiology, Biology or related field with experience in a biologics, cell therapy or sterile drug product QC microbiology.
Expert knowledge of common QC 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 with isolator technology.
Experience in manufacturing facility startup is highly desirable.
Knowledge of cell therapy or biologics manufacturing is highly desirable.
Knowledge of US and EU cGMP regulations and guidance.
Self-directed with a high degree of professional integrity, highly organized and detail oriented.
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.
Company: Bristol Myers Squibb
Req Number: R1532846-en-us
Updated: 2020-11-25 02:55:16.709 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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