Person in Plant External Manufacturing Houston Based (East Brunswick,N
Location: East Brunswick
Posted on: May 11, 2019
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
This position will initially be based in Houston, TX for 12-18
months, potentially longer.
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
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
- 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
- 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
- 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
- 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
- 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.
- 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
- Strong technical background in aseptic operations.
- Solid project management skills and experience managing complex
- Ability to influence senior management both internally and
- 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
- Bachelor s degree in Life Sciences or related discipline
(Immunology, Microbiology, Cell Biology, Engineering, etc.).
- Advanced degree in Life Sciences preferred.#LI-POST
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
\"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, biology, biomedical, enzyme, medical, neuro,
nutrition, pharmaceutical, therapeutic
Keywords: Celgene, East Brunswick , Person in Plant External Manufacturing Houston Based (East Brunswick,N, Other , East Brunswick, New Jersey
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