Associate Director, Attribute Science

Employer
Celgene
Location
Warren, NJ, US
Posted
Nov 21, 2018
Ref
1803866
Required Education
Doctorate/PHD/MD
Position Type
Full time
Req #: 1803866
Location: Warren, New Jersey, United States
Job Category: Technical Development
Work Location: 7 Powder Horn Drive 07059
Organization: Pharmaceutical Development
Employee Status: Full-time
Job Type: Regular

Associate Director, Attribute Science, Product Sciences

This is a scientific leadership role in Product Science Group within Cell Therapy Development & Operations (CTDO) at Celgene, whose mission is the definition of critical quality attribute (CQA) for cell therapy products. Specifically, the incumbent is responsible for overseeing the development of analytical methods for characterization of cell therapy products, both from the internal Celgene pipelines and from third-party collaborations, from candidate nomination through life-cycle management. In addition, the ability to lead cross-functional teams focused on developing gene-engineered T cell product characterization strategies and identification of CQA through correlative analysis. This individual is also responsible for supporting regulatory submissions, including authoring, reviewing and approving regulatory documents

Responsibilities include, but are not limited to:
  • Lead Attribute Science group with responsibility of CQA definition and product characterization, including assay development, high throughput screening, data analysis and management,
  • Lead and expand Attribute Science team within the Product Science organization to meet the expanding needs of the Celgene Cell Therapy pipelines.
  • Lead the overall scientific, technical and operational efforts within Product Science organization with regards to hypothesis generation, product characterization methods development, lead new assay conceptualization & selection.
  • Support process monitoring and characterization, including starting material and process intermediate. Together with Process and Analytical Development, design and execute the comparability study.
  • Provide SME support and provide CMC root cause analysis for clinical investigation.
  • Deliver timely data and process knowledge needed to meet Celgene project milestones and associated regulatory requirements.
  • Build the capabilities, and phase appropriate strategies that enable fast to market product development and commercialization. Maintain current awareness in areas of expertise.
  • Collaborate extensively and effectively with business partners inside and outside CTDO to deliver mission-critical tasks and milestones.
  • Provide functional supports to regulatory submissions and interactions, such as author, review and approve regulatory documents.
  • Maintain currency with applicable global regulations and industry standards for analytical methods and testing of cell therapy products.
  • Identify and establish partnerships with external vendors to leverage capabilities not available in-house.
  • Share responsibility for the group's scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support discovery and product development.
  • Develop the attribute science staff to function effectively in cross-functional teams and collaborations and provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel-related activities across CTDO

Skills/Knowledge Required:
  • Ph.D. in immunology, cell biology or other relevant scientific discipline required
  • 10 years pharmaceutical analytical experience with exposure to all stages of cell therapy or biologics development
  • Direct experience in analytical development and regulatory requirements to support early and late-stage product development and global commercial registration submissions
  • Proven leadership ability to align, motivate and empower team members
  • Strong sense of value of investment and the ability to develop cost-effective development plans
  • Effective communication, collaboration, and negotiation
  • Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment, and with CRO


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.