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Sr Manager, Biologics DS Dev

Req #: 1800353
Location: Summit, NJ US
Job Category: Project Leadership
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, Biologics DS Development - Project Management

Summit, NJ
 

PREREQUISITES

PhD or MS in molecular biology, biochemical/chemical engineering, biological sciences or relevant discipline with over 10 years (for Ph.D.) or over 15 years (for MS) of biopharmaceutical or biotech industrial DS process development experience for production of recombinant therapeutic proteins

Reporting to the head of Biologics DS Development, this Senior Manager position will focus initially on a bispecific program to manage the complex interface with CDMO, CMC timeline, technical discussions and technology transfer, and be responsible for managing coordination of activities among different DS development function groups (CLD, USP and DSP), towards IND submission by the year end of 2017.

Responsibilities will include, but are not limited to, the following:

Manage complex interactions between DS CDMO and internal DS development functions, including technical discussions, technology transfer, etc. Will also act as the interim CMC PM in CMC subteam of a bispecific program. Manage coordination of internal and external activities between CLD, USP and DSP for development of new DS candidates Ensure DS development programs (internal and external) are executed to planned timelines, deliverables and budgets. Manage interface of DS development with key business partners across Celgene. Plan and deliver DS quantities for research activities, GLP studies and the first clinical supply Schedule, organize and file DS source documents to enable future reference and for regulatory purpose Organize and oversee preparation and execution of contracts, work orders and invoices. Ensure timely completion Prepare DS development budgets and track expenditure.  Interface with FP&A staff for monthly reporting and forecasting. Lead resource planning and mapping for DS development projects and workforce planning

Skills/Knowledge Required:

  • Extensive DS development experience in biopharmaceutical or biotech industry.
  • Have knowledge in regulatory guidelines and regulatory document preparation
  • The candidate must be well organized and have excellent oral and written communication skills, and be able to communicate and connect with all levels of the organization.
  • Demonstrated ability to function in a collaborative/team oriented environment. To be able to drive project according to project timeline.

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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