QC Manager, Bioseparations

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.

Major Duties and Responsibilities:

• Manages QC analysts and Leads in Bioseparations laboratories performing in process, release and stability testing for the effective operations of a biologics manufacturing facility.
• Manages QC testing responsibilities to ensure completeness, timeliness and overall compliance.
• Ensures cGMP compliance in all aspects of laboratory operations and supports regulatory inspections and audits.
• Develops and implements SOPs for various Quality Control operational procedures including but not limited to: training, trending, equipment maintenance and calibration, method execution, investigations, and Laboratory processes.
• Oversees change controls and laboratory investigations within their team.
• Oversees the implementation of continuous improvement within their team using Operational Excellence and Lean principles.
• Ensures that data review, trending analyses and protocol and report generation are performed to support all areas of laboratory operations.
• Recruits and develops a high performing team with diverse backgrounds and talents. Coaches and counsels team members to develop their skill sets and create an environment of continuous learning, improvement, and innovation.
• Maintains and communicates performance metrics for her/his team, setting and maintaining high expectations for team performance.
• Develops and drives staff schedules to meet workflow demands and monitors expenditures to prevent budget overruns.
• Provides leadership, direction and communication of business critical information to staff.

Knowledge and Skills:

• Knowledge of science generally attained through studies resulting in a B.S. in science - chemistry, biochemistry, a related discipline - or its equivalent is required.
• A minimum of 6 years experience in biopharmaceutical quality with a minimum of 2 years of laboratory management responsibility with an advanced degree or 10 years experience with a bachelor's degree.
• Strong background and demonstrated effectiveness with method validation transfer for biologics methodology.
• Background/Experience with implementation of Lean principles.
• Extensive knowledge of US and EU cGMP regulations and guidance.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Knowledge of applicable business systems including: SAP, LIMS, Trackwise and laboratory EDMS preferred.
• Experience with regulatory agency (FDA, EMEA, TGA) inspections preferred.

Decision Making:

• Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercises judgment with in generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as an advisor to subordinate staff to resolve problems. Develops performance requirements and evaluates analysts accordingly. Establishes and recommends changes to policies which affect subordinate organization. Develops a coaching and mentoring environment for subordinates that fosters open communication. Works with peers to ensure alignment of priorities and agreement of project ownership

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.