Microbiology Center of Excellence Lead, Analytical Strategy & Operatio
Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: February 2, 2019
Microbiology Center of Excellence Lead, Analytical Strategy & OperationsScope: There are three key categories to the scope of this role: Develop, implement and lead a Microbiology CoE organization with clinical through commercial lifecycle responsibilities that will drive a network microbiology focus at BMS, and influence microbiological science and practices at development and commercial sites around the world.Drive network microbiology standards and provide savings from aligned practices, procedures and projects.Evaluate new technologies , develop global strategies for capital purchases and implementation, and lead deployment to the sites The Microbiology Center of Excellence Lead (MCEL) for Analytical Strategy & Operations is a motivated and adaptable leader in Product Development who supports development and global commercial manufacturing networks. The MCEL is a microbiology SME, strategist, and operational integrator and implementer tasked with aligning/implementing microbiological strategies, procedures and practices across operations. They also provide microbiological expertise and method development support for product development clinical programs.The scope of the responsibilities of the MCEL Lead fall into the three categories described above. In fulfilling these responsibilities, the MCEL will contribute to the long-term success of ASO, PD, and GPS by advancing network microbiology performance and commitment to quality and compliance.Key responsibilities
- Establish, lead and staff the Microbiology CoE, an organization with end-to-end responsibilities from the development of methods and technologies, their subsequent transfer, and ownership through commercial lifecycle.
- Provide strategic microbiology leadership, working directly with development and commercial site microbiology leads and other key members of Operations, IT and Quality functions.
- Drive the alignment of microbiological best practices and facilitate the streamlining of procedural documents for the microbiology network.
- Lead efforts to evaluate existing practices and look for alternative approaches to simplify and streamline ways of working that can deliver higher quality results faster at reduced cost.
- Provide guidance and feedback to drug development teams, commercial sites and regulatory functions in responding to health authorities worldwide. -- Manage, train, develop and mentor personnel to achieve a high performing team..
- Provide expertise and assistance to troubleshoot and resolve plant / product microbiology issues.
- Drive the evaluation/implementation of rapid microbiological methods and the enterprise wide adoption of environmental monitoring software and other emerging IT solutions, working cross functionally with product development and global manufacturing to ensure solutions are applicable to site needs.
- Participate in internal and external industry forums to understand evolving regulatory expectations and industry best practices. Professional experience and qualifications BA/MS/PhD Degree in Microbiology or other relevant discipline.Minimum 15 years of pharmaceutical microbiology experience, including commercial QC microbiology in a parenteral manufacturing environment.Experience working in a cGMP-regulated environment, primarily gained through direct microbiological support of commercial manufacturing. Advanced knowledge of CMC and related manufacturing guidances and regulations to guide the compliance and drive science based submissions and responses to the health authorities Experience with rapid microbiology methods preferred Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures. Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization. Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end-to-end enterprise) and makes the best decisions for the whole.Active involvement in pharmaceutical industry professional groups and forumsExcellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders in this capacity and be seen as a highly regarded and a credible leader with the ability to act on VP of Analytical Strategies & Operations behalf for interfaces with stakeholders in a matrix environment. Proven track record of delivering results and is action oriented.Leadership Requirements Enterprise Mindset Understands the big picture, beyond their own functional area. Leads within the broader internal and external network, and seeks to have impact on organization-wide performance.Embraces complexity, but strives for simplicity.Shares resources and makes difficult trade-offs to benefit the organization at large. Change Agility Creates a vision for the future by spotting strategic opportunities for breakthrough performance.Translates the case for change into actionable plans for the organization.Demonstrates smart risk-taking and personal resilience when implementing change.Enables others to navigate change with confidence and in sustainable ways. Authentic Leadership Demonstrates an honest and unbiased understanding of their own strengths, limitations, and values.Lives up to their principles and conviction without being rigid or dogmatic. Generates trust by maintaining the highest level of consistency between their words and their actions Talent Developer Maintains a current and strategic view of talent management, aligned with the organization's priorities.Understands the needs and characteristics of the organization's talent and the extent to which it supports the business agenda. Proactively develops talent for the long and short-term, both within and outside their team.Creates a learning environment that ensures people realize their highest potential.
Keywords: Bristol-Myers Squibb Company, New Brunswick , Microbiology Center of Excellence Lead, Analytical Strategy & Operatio, Other , New Brunswick, New Jersey
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