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Associate Manager, Biologics Analytical CRO Operations

Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: February 9, 2020

Job Description:

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 role will support the Biologics Development and Manufacturing Sciences and Technologies area core functions with the planning, creation and execution of CMC development projects with external parties under the sponsorship of ASO. The position will require extensive interfacing with inter disciplinary scientific staff, Quality, Global Procurement, Finance, Legal and other functional areas. This role provides an excellent opportunity to utilize both a scientific and project management background to contribute to the advancement of our growing and exciting portfolio.Responsibilities include:

  • Liaise between development scientists and contract research organizations (CROs) and coordinates project work at CROs.
  • Facilitates project progress meetings with CROs, perform issue resolution and escalations and complete project close out activities
  • Reviews project needs, estimate funds, facilitates SOWs and POs, and manages invoices.
  • Manages the maintenance of the outsourced book-of-work database for select strategic partners.
  • Ensures that CROs follow applicable SOPs and Quality Agreements.
  • Supports Suppliers Relationship Management (negotiate pricing, contracting, metrics tracking).
  • Ensures compliance with and maintains required training in relevant BMS and departmental GMP, GLP, SOP, safety and other guidelines.Qualifications:
    • Bachelor's degree in Biology, Biotechnology, Chemistry or related discipline with minimum 5 years of experience within the pharmaceutical industry and with a focus in the area of CMC development of Biologics compounds.
    • Candidates who possess an advanced degree or a business degree would be preferred.
    • Experience in managing CRO/CTOs, primarily in the area of analytical support is required.
    • Understanding the experience of the drug development process and associated regulatory framework is essential.
    • Thorough understanding of cGMP's is strongly preferred.
    • Must be able to work across and influence multi-departmental initiatives, work independently and with minimal supervision.
    • Working knowledge of project management skills such as facilitation, planning, financial analysis, budgeting, change management, stakeholder alignment, and communication planning and results delivery.
    • Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, OneNote) and business systems such as SAP/Ariba are essential.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.

Keywords: Bristol-Myers Squibb Company, New Brunswick , Associate Manager, Biologics Analytical CRO Operations, Executive , New Brunswick, New Jersey

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