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 a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.General Summary:
The Sr. Manager, QC Microbiology is a full-time position that plays a key role in leading the objectives of the contamination control strategy at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The primary focus for this role is the maintenance and continuing improvement of business processes specific to the JuMP Environmental Monitoring (EM) program and microbiology programs. This role focuses on contamination control program, sterility assurance, risk assessments, trending and interpretation of EM data, and oversight of the EM excursion business process. The Sr. Manager, QC Microbiology owns investigations, owns change controls, provides impact assessments to changes related to contamination control and sterility assurance and is a subject matter expert for topics related to microbiology and sterility assurance. Additionally, this role works closely with stakeholders in manufacturing, engineering, and validation to drive alignment to site contamination control goals and standards. The Sr. Manager, QC Microbiology is a Subject Matter Expert for compendial and rapid microbiology laboratory methods, and serves as the technical lead for evaluation, validation, and implementation of new microbiology methods. The Sr. Manager role supports and participates in regulatory audit, drafts audit responses.Minimum RequirementsEducation:
Bachelor's degree, preferably in biology, microbiology, or biochemistryExperience
- Fifteen years experience in a cGMP/FDA-regulated environment
- Experience with application of root cause analysis tools for the purpose of investigation execution
- Well versed with regulations and experienced in presenting to regulatory auditors from US, EU
- Experience and extensive understanding of environmental control regulations and guidelines with in-depth knowledge of cGMPs
- Proven experience working as a detailed-oriented team player with effective planning, organization and execution skills
- Strong computer skills with MS Office (e.g. Word, Visio and Excel)
- Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables
- Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Experience with Quality Systems (e.g. Document Management System, Quality Management System, Learning Management System, Change Control, Deviations, and CAPA programs)
- Oversight of the EM excursion business process, and metrics relating to the health of the process
- Execute and continually improve the contamination control program, EM trend program
- Compile and evaluate EM data for specific initiatives related to the strengthening of the JuMP contamination control strategy
- In addition to interpretation of EM data, provide technical expertise for interpretation of data in support of root cause analysis and continuous improvement of processes such as cleaning, gowning, and facility flow.
- Subject matter expert for sterility assurance
- Regulatory audit participation experience
- Proficient in Microsoft Office programs, with advanced/expert proficiency in MS Excel.
- Good interpersonal skills and ability to work with others in a positive, collaborative manner.
- Ability to work independently and perform with a high degree of accuracy.
- Ability to learn and apply Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices.
- Experience in GMP-regulated environment is preferred, working knowledge of Good Manufacturing Practices (21 CFR 210/211, 600, & 820).
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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