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
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

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


Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.