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Manager, External Manufacturing

Posted on May 19, 2019 by Celgene

Not Specified, Germany
Manufacturing
Immediate Start
Annual Salary
Full-Time
Req #:
Location: Offsite, Germany
Job Category: Technical Development
Work Location: OFFSITE
Organization: Manufacturing
Employee Status: Full-time
Job Type: Regular

At Celgene, we're committed to changing the course of human health through bold pursuits in science, life-enhancing therapies and a promise to always put patients first. At the core of that mission are the talented individuals on our Global Cell Therapy Quality team who collaborate globally and cross-functionally to drive innovation.
Join our team as an External Manufacturing Manager, and help us deliver truly innovative and life-changing medications to our patients worldwide.

What great looks like in this role
The primary focus of the Person-in-Plant, External Manufacturing role is to oversee Celgene's critical cell processing 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 ongoing cGMP supply of cell manufacturing.

To be successful in this role, you will need to be strategic, understand the challenges and impact of close oversight and management of CMO partners. You'll need demonstrated decision-making skills, leveraging business insights for innovative compliance and technical solutions, as well as a strong operational, quality, compliance and technical background, with proven project management and supplier relationship management abilities within commercial (post-approval) operations.

You'll be located at the cell processing CMO's site with an ability to travel elsewhere as needed. 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. You 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.

Responsibilities
The key deliverables for this role are to ensure reliable cell processing 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 cell processing; 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).


Knowledge and skills required:

  • Bachelor's degree required, ideally in cell biology, or closely related disciplines; advanced degree in Life Sciences preferred.
  • 5+ 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.

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.

#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.

Reference: 708579667