Director, IT Site Lead - Manufacturing

Job Description

Req #: 1903259
Location: Bothell, Washington, United States
Job Category: Information Technology
Work Location: 1522 217th Pl SE 98021
Organization: Information Technology
Employee Status: Full-time
Job Type: Regular
Other Locations: United States-California-Los Angeles, United States-California-San Diego, United States-California-San Francisco

Juno Therapeutics, a Celgene company, is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.Juno Therapeutics is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.
Learn more about Celgene's CAR T team and hear what they have to say about the amazing work they’re doing in the world of medicine here: https://www.youtube.com/watch?v=QGp_lyopogY&feature=youtu.be
Summary:
Based in Bothell, Washington, the Director - IT Site Lead GPDO position plays a critical role in managing all corporately supported infrastructure and software at the Cell Therapy manufacturing site. Celgene IT is committed to achieving excellence as measured (in part) by their effectiveness in supporting business functions and related business processes across the company. The role must excel at supporting the site’s daily operations while also developing a strategic IT roadmap for the site.
Responsibilities will include, but are not limited to the following:

• Lead a matrixed organization composed of both site direct reports and groups of indirect reports to deliver effective, innovative and stable solutions that meet the needs of the site.
• Be an active member of the Site Leadership team. Collaborate with site leadership to develop, support, and align strategies for business process improvements through information systems automation.
• Accountable for site representation at CAB (Change Advisory Board) meetings to prioritize requests for new system capabilities and functions while ensuring alignment of technologies across Cell Therapy sites.
• Function as the liaison and the single point of contact between site leadership and corporate IT.
• Accountable for continuous operation and maintenance of ERP, MES, LIMS, local manufacturing, quality control and quality management site IT systems as well as associated site infrastructure.
• Lead Cell Therapy site service level management scope and process with IT groups and/or vendor managed services, i.e. Service Level Agreements (SLA’s), Disaster Recovery/Service Continuity, etc.
• Provide IT leadership to site inspection readiness and data integrity initiatives.
• Participate in high-level strategic communications with the business and site leadership teams.
• Manage new demand from the various site functions (Manufacturing Operations, Quality, Supply Chain, Manufacturing Science & Technology) through the IT Stage Gate process.
• Identify key technology trends and how new technologies might be leveraged to provide better solutions to the manufacturing site.

Required Qualifications:

• Bachelor's degree in IT, engineering, mathematics, accounting, chemistry, biology, or related field. Advanced degree preferred.
• Greater than 9 years in multiple organizational contexts, including IT site management, linking technology to business needs in the biopharmaceutical industry.
• Experience in information technology, preferably within a pharmaceutical technical operations environment. Experience should range from manufacturing and quality control systems to GxP quality management systems.
• Demonstrated effective leadership skills in building high performance teams.
• Excellent skills in change management, staff mentoring, performance evaluation, life-long learning, and diagnosis of sources of problems in both technology and business processes.
• Deep knowledge of regulatory requirements in the areas of current Good Manufacturing Process (cGMP).
• Understanding of regulatory requirements and the role technology plays in satisfying those requirements is essential to this position.
• Thorough understanding of best practices in SDLC and ITIL.
• Strong understanding of IT disaster recovery solutions and planning.
• Understanding of financial concepts, TCO, and ROI.
• Ability to work strategically and independently with internal and external groups on multiple projects.
• Must be client service-driven with excellent relationship management and analytical skills.
• Flexible, adaptable and hands-on approach necessary.
• Experience in implementing IT strategies and a technology roadmap for multiple clients.
• Exceptional communication and leadership skills as evidenced in small and large organizations.

Preferred qualifications:

• MES, LIMS, and Delta V working experience.
• Experience working with cell therapy manufacturing.

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.