Supervisor QC Microbiology

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.
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

• 8+ year 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.

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 the resources to pursue their goals, both at work and in their personal lives.