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Supervisor QC Microbiology

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Company :
Bristol-Myers Squibb

Location :
Bothell, Washington

Expiry Date :
Sun, 13 Dec 2020 23:59:59 GMT

Apply Job :
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Description :
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through 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. This is a Wed – Sat PM Shift (1:30p – midnight) GENERAL SUMMARY The QC Microbiology Supervisor is a full-time position. This role is responsible for the day to day operations associated with the in-process and release testing of clinical and commercial autologous cell therapy product. The QC Supervisor will be a key leader responsible for GMP operations and meeting critical business goals. MINIMUM REQUIREMENTS Education: – BS in a scientific discipline. Experience – 6+ years of regulated industry experience Knowledge, Skills, and Abilities – Strong working knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. – Demonstrated experience building and leading exceptional teams – Ability to apply Lean, Six Sigma and Risk Management concepts and tools is preferred. – Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects. – Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others. – Demonstrated success working in a high-performing, business results-driven environment. ESSENTIAL DUTIES Key Responsibilities – Provide supervision of Quality Control (QC) associates and oversees the day to day activities related to in-process, final release and stability testing of drug product. – Develops and manages a daily work plan for QC associates. – Hire, mentor and develop exceptional QC personnel. – Identifies and mitigates risks in QC labs that could negatively impact the safety, identity, strength purity or quality of the product. – Assists in the design, implementation and continuous improvement of Quality Control systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements. – Provides leadership support during trouble shooting of assay performance and equipment as it relates to ensuring the quality and compliance of the product. – Ensures deviations, CAPA, change controls, process transfers, and other business drivers are supported in a compliant manner. 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.