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Person in Plant External Manufacturing Houston Based (Lakewood,NJ)

Company: Celgene
Location: Lakewood
Posted on: May 19, 2019

Job Description:

Req #:
Location: Offsite, New Jersey, United States
Job Category: Technical Development
Work Location: OFFSITE
Organization: Supply Chain
Employee Status: Full-time
Job Type: Regular
Other Locations: United States-California-Offsite, United States-Texas-Dallas
This position will initially be based in Houston, TX for 12-18 months, potentially longer.

Job Summary

The primary focus of the Person-in-Plant, External Manufacturing role is to oversee Celgene s critical vector Contract Manufacturing Organizations (CMOs). We are looking for a demonstrated leader with the breadth of professional experience and the drive to work with both internal and external partners to define and implement our vision for this business-critical function and ensure the robust supply of viral vector. The right candidate will be strategic, understand the challenges and impact of close oversight and management of CMO partners.

This candidate will need demonstrated decision-making skills, leveraging business insights for innovative compliance and technical solutions. The ideal candidate will have a strong operational, quality, compliance and technical background, with proven project management and supplier relationship management abilities within commercial (post-approval) operations. The candidate will be expected to be highly mobile, able to spend extended periods located at CMO site(s) and be comfortable working remotely.

As we are changing medicine for good, we need someone who is used to working in a highly matrixed and cross-functional organization, against tight deadlines, and with world-class contract manufacturers and business leaders alike. The successful candidate should also expect some diversity of work and scope as well, as a key member of the Virtual Plant Team (VPT) but also contributing to the broader External Manufacturing group activities.

The key deliverables for this role are to ensure reliable vector supply through:

  • Close oversight of Contract Manufacturing Organizations (CMOs), assuring manufacturing meets or exceeds Celgene s expectations (cost, quality, cycle time, yield, other deliverables).
  • On-site presence at the CMO facility for extended periods, leading up to and during manufacturing campaigns; being the first point of contact for the CMO when issues are encountered.
  • Sound decision-making may be required with limited governance and oversight for immediate and off-hours issue resolution, followed by prompt escalation to the appropriate internal stakeholders.
  • Providing technical, quality and regulatory guidance to our CMOs, leveraging internal SMEs, as some of our CMOs may not have extensive commercial or inspectional experience.
  • Working closely with CMO and internal Quality and Technical teams to complete investigations and deviations, acting as the key liaison for efficient CMO documentation to meet our expectations and needs.
  • Facilitating post-campaign and CAPA effectiveness review at CMOs; ensuring internal/external audit observation deadlines or other regulator commitments are met on-time.
  • Engaging internal stakeholders, as needed, for change management, issue resolution and adherence to agreed deliveries.
  • Collaborating with CMO to understand planned changes, then driving review and prioritization of these changes with the VPT; managing the associated change controls and impact assessments; managing the change through to full implementation.
  • Building and maintaining strategic relationships with our strategic CMOs as well as managing relationships with key internal stakeholders.
  • Overseeing CMO execution and performance, conducting regular monitoring and gathering data to enable solid Supplier Relationship Management (metrics, KPIs).Primary Responsibilities
    Serve as the Celgene Person-in-Plant for operational and supplier relationship activities; be the eyes and ears for the VPT at the CMO for flawless execution of commercial operations. Identify and escalate business-critical issues effecting Compliance, Operations and Management to senior management as necessary . Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing. Engage internal stakeholders (Quality, Technical Operations, Regulatory, etc) for troubleshooting and management of in depth process investigations, as appropriate. Partner with key internal stakeholders to establish and lead a benchmark vendor management program, including data-management for KPIs and development of appropriate metrics. Partner with key internal stakeholders to draft, manage, and deliver on annual CMO related goals, objectives, and operating budget. Act as key point to manage jointly-agreed change controls, through full implementation. Proactively identify and drive continuous improvement opportunities and effectively lead timely resolution of supply issues. Live the Celgene values.

    Required Qualifications
    • Bachelor s degree required, ideally in; cell biology, or closely related disciplines.
    • 10+ years of experience working in biopharmaceutical manufacturing, quality, or biopharmaceutical development.
    • Strong quality and compliance background in a commercial GMP operational environment; sound working knowledge of health authority regulations
    • Strong technical background in aseptic operations.
    • Solid project management skills and experience managing complex projects.
    • Ability to influence senior management both internally and externally.
    • Ability to expresses one s self clearly and concisely to key stakeholders; documents issues and/or concerns concisely and comprehensively; adjusting style, language and/or terminology as appropriate for the audience .
    • Strong leadership and an innate ability to collaborate and build relationships is critical.
    • Thorough understanding of supplier relationship management principles, including the best tools and processes to facilitate objective (data-based) engagement.
    • Willingness to do what needs to be done, often without a strong team immediately nearby.
    • Flexibility to work shift hours required to cover critical process steps and represent Celgene as a leader when issues arise.Education Requirements
      • Bachelor s degree in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.).
      • Advanced degree in Life Sciences preferred.#LI-POST

        About Us

        COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

        At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

        \"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.\"

        There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: bio, biological engineer, biomedical engineer, biophysics, bioprocessing, biosynthetic, msat, parenteral, pathogenesis, pharmaceutical

Keywords: Celgene, Lakewood , Person in Plant External Manufacturing Houston Based (Lakewood,NJ), Other , Lakewood, New Jersey

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