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Sr. Manager, QC Incoming (Raw Materials)

Req #: 1701009
Location: Summit, NJ US
Job Category: Quality
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit West

Description

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.

Sr Manager, QC Incoming (Raw Materials)

Summit, NJ

Responsibilities include, but are not limited to:

Manage personnel and complex/ diverse tasks that directly support testing and release of consumables and raw materials used in CAR-T manufacturing during clinical and commercial phases.

  • Maintain oversight of contract testing laboratories
  • Manage GMP releases for all incoming consumables/raw materials
  • Manage and maintain all documentation needed for GMP release activities
  • Manage method development and validation for all incoming consumables/raw materials, as applicable
  • Develop and lead strategy for raw material qualification for clinical and commercial manufacturing
  • Qualify alternative sources and vendors for consumables/raw materials, as applicable
  • Support the development and career progression of laboratory personnel

Skills/Knowledge Required:

  • BS/MS or equivalent in a life science related field
  • Fluent in speaking/writing in English
  • Minimum of nine (9) years of relevant experience in a manufacturing environment for small molecules, biologics, or cell therapy products
  • Minimum of three (3) years of leadership experience
  • Advanced understanding of Pharmaceutical/cell therapy regulatory requirements and their impact to commercial laboratory operations
  • Advanced knowledge of global cGMPs, ICH, USP, JP, and EP
  • Advanced understanding of technical purpose and capability of laboratory instrumentation, software, and techniques
  • Experience auditing suppliers
  • Ability to plan, prioritize and execute multiple tasks simultaneously under tight deadlines
  • Ability to manage projects and lead teams utilizing modern project management methodology and tools
  • Advanced written and verbal communication skills
  • Ability to effectively network and benchmark within and outside the organization
  • Ability to challenge processes to improve quality, efficiency, and compliance
  • Ability to use risk based approaches to determine impact/resolution
  • Ability to work independently for extended periods of time
  • Proficiency in Microsoft Office applications

#LI-POST

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.
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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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