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CMC Data Steward

Company: Celgene
Location: Seattle
Posted on: December 5, 2019

Job Description:

Req #: 1901567
Location: Seattle, Washington, United States
Job Category: Technical Development
Work Location: 400 Dexter Ave N. 98109
Organization: Bioengineering
Employee Status: Full-time
Job Type: Regular
Job Summary

CMC Data Steward is a key technical role in global MSAT that works across multiple functions in Cell Therapy Development and operations (CTDO) to develop a sustainable manufacturing data lake strategy within cell therapy manufacturing network and respond to/manage ongoing CMC data requests originating from a diverse stakeholder within CTDO, manufacturing network, regulatory, clinical, CMC and TCT product teams. A successful candidate in this role will not only provide timely response to the data requests but also develop data management systems and infrastructure to enable a sustainable approach to such requests. The candidate is expected to guide/influence our collective thinking on identifying the right data set to answer the specific scientific question at hand and also direct the teams to the appropriate level of data verification/integrity requirements suitable for intended purpose of the data use. The role is at the center of everything we do in CTDO including process control strategy, continuous process verification, correlative analysis, process improvements to ultimately further our product and process knowledge. As such this role requires an individual who is not only skilled at navigating the complex set of data sources in a multi-site/multi-node complex global supply chain essential for cell therapy commercialization, but also has a sound understanding of the manufacturing process parameters and product attributes. The Sr. Process Engineer will play a key role in product lifecycle management, including development, characterization, commercialization of Celgene s of cell therapy products.

Primary Responsibilities

  • Serve as a single point of contact for managing CMC data requests in CTDO for late stage/commercial products.
  • Work with the drug product and vector MSAT teams to ensure access/availability of the manufacturing data in support of continuous verification programs
  • Serve as the MSAT member of the Celgene s correlative analysis team to ensure team has the access to the needed manufacturing data, contribute to the process/product knowledge understanding through this effort and bring the insights back to the MSAT team to drive process life cycle management plan
  • Collaborate with data stewards and other stakeholders in CTDO to share data management best practices across development and manufacturing, and drive design of data policies, standards and procedures.
  • Develop and maintain metadata and controlled vocabulary business terms (definitions and business rules) and other artifacts associated with the control and data standardization of data assets; and ensure that they are properly reviewed and approved by the Data Owners. Implement, maintain and monitor data quality requirements and business rules for assigned data assets and data attributes.
  • Work with internal and external manufacturing sites to ensure ongoing manufacturing data is captured in a standardized way across sites in a single global database
  • Identify systems, tools needed to manage the data lake and work with internal and external IT experts to simplify manufacturing data access
  • Support investigation teams to troubleshoot atypical observations/non-conformances by providing the necessary data and insights to help identify root cause
  • Serve as a point person to provide historical manufacturing data sets needed to establish and comparability and qualification protocols
  • Improve workflow and processes followed for managing data requests to continue to simply and improve lead time for such requests
  • Define the necessary level of data integrity/verifications required based on intended use.
  • Responsibilities of this role include using software tools and systems to collect data sets that support advanced analytics of cell therapy manufacturing data.
  • Train end-users on the use and maintenance of data management tools and systems. Assist in the transfer of tools and analytical methods to other functional groups, as needed
    BASIC Qualifications
    • B.S. or M.S in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 6+ years relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
    • Experience working with various IT systems/automation platforms.
    • 3+ years of experience working in a GMP environment
    • Demonstrated ability to effectively work in cross functional teams in a fast-paced environment
    • Excellent problem-solving skills.
    • Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
    • Strong scientific and technical writing.
    • Excellent verbal and written communication skills to be able to communicate with a diverse audience with variable level of technical understanding of the systems and manufacturing processes
    • Knowledge of MES and LIMS systems
    • Ability to write scripts, specifically in VBA, Python, SQL, R-script, or C# is preferred
      PREFERRED QUALIFICATIONS
      • Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes.
      • Knowledge of cellular immunology a plus.
      • Experience working with databases such as Oracle or SQL Manager is preferred.


        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: analysis, business, business intelligence, business systems analyst, financial analyst, government, investment analytics, regulation, strategy, valuation analyst

Keywords: Celgene, Seattle , CMC Data Steward, Other , Seattle, Washington

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