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Senior Manager, Biologics Analytical CRO Operations

Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: January 8, 2021

Job Description:

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In 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 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 are established to drive outsourced project planning and execution:

  • Scope of work (Defining milestones, deliverables and timelines in collaboration with functional area SME's)
  • Development and execution of associated contracts in accordance with corporate policies
  • Project start-up (establishment of key contacts, communication plan, project kick-off meetings, etc.)Outsourcing oversight including:
    • Monitoring of external project activities, facilitating and/or lead project progress meetings with contract research organizations (CROs), perform issue resolution and escalations and complete project close out activities
    • Manages the maintenance of the outsourced book-of-work database for select strategic partners.
    • Establishes and maintains relationships with CROs, coordinates project work, collaborates with Global Procurement to support SRM (negotiate pricing, contracting, metrics tracking).
    • Ensures that CROs follow applicable SOPs and Quality Agreements, evaluates CROs through onsite visits and can assist/shadow in technical audits of CROs.
    • Liaise between development scientists and CROs.
    • Reviews project needs; estimates resources, funds and facilitates need for external work. Make recommendations when appropriate to move external work to internally supported work streams within ASO or other collaborators.
    • Manage internal staff as needed.
    • Ensures compliance with and maintains required training in relevant BMS and departmental GMP, GLP, SOP, safety and other guidelines.Travel would be required (-5%).Requirements:
      • Bachelor's degree in Biology, Biotechnology, Chemistry or related discipline with 7 or more years of experience within the pharmaceutical industry and with a focus in the area of CMC development of Biologics compounds.
      • Strong verbal and written communication skills
      • Experience in managing CRO/CTOs, primarily in the area of analytical support
      • Ability to build strong working relationships with internal and external partners, work well with matrix teams and effectively manage activities across a complex portfolio of projects with minimal supervision and a high sense of urgency.
      • Understanding the drug development process and associated regulatory framework is essential.
      • Ability 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, communication planning and results delivery.Ideal Candidates Would Also Have:
        • Candidates who possess or are pursuing an advanced degree or a business degree
        • Thorough understanding of cGMP's is strongly preferred
        • Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, OneNote) and business systems such as SAP/Ariba are essential.BMSBLAround 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.

Keywords: Bristol Myers Squibb, New Brunswick , Senior Manager, Biologics Analytical CRO Operations, Executive , New Brunswick, New Jersey

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