Celgene Manager CMC, T Cell Science & Technology in Summit, New Jersey

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.

We seek a highly motivated CMC manager with demonstrated expertise in drug product development to drive clinical supply activities that support CAR-T global clinical trials and advance rapid commercialization of CAR-T therapies. The primary responsibility of this role is to release CAR-T products manufactured by CMOs to support clinical trials in Europe and Asia-Pacific in collaboration with QA. The successful candidate will be required to use CMC technical knowledge & expertise to establish in-house process and QC review capacities to support CAR-T product release partnering with QA. This qualified candidate will work closely with Global Quality Operations team and provide them with necessary technical support. This position will also involve extensive interaction with collaboration partners’ technical & quality teams and collaboration within cross-functional Celgene teams.

Responsibilities will include, but are not limited to:

  • Lead clinical CAR-T product release activities from technical perspective.

  • Develop product release workflow.

  • Review manufacturing batch records and product associated documents for clinical CAR-T product release.

  • Manage deviations/OOS/CAPA in Celgene compliance system for clinical CAR-T product release.

  • Partner closely with QA on above activities.

  • Review analytical data for clinical CAR-T product release.

  • Generate Certificate of Analysis (CoA) for CAR-T clinical product release.

  • Tracks and reports performance metrics as required.

  • Interface with contract manufacturers and testing laboratories to communicate and promptly resolve product issues.

  • Manage change control through impact assessments, tracking and implementation.

  • Provide necessary technical support to Celgene Quality Operations (quality document review, audit support, risk assessment, etc.)

  • Manage all project-related documentation (all SOPs, important technical reports, etc.) in Celgene’s documentation system and manage the version change.

  • Participate in tech transfer activities from Juno to EU CMO.

  • Provide necessary technical input to support regulatory submission.

  • Serve as a technical and product quality SME from CMC in cross-functional teams and support execution of process operational strategies.

  • Interact with other CMC teams, Quality operation, Clinical Operation, Regulatory and other personnel as dictated by project need. Contribute in a team-oriented environment to achieve common project goals.

  • Maintain knowledge of scientific literature and apply key concepts to project activities/plans.

  • Build on experience and adapt approaches to expand and develop operations as the program extends into Europe and Asia-Pacific.

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BIO-PRIORITY

Qualifications

Prerequisite:

  • BS/MS in relevant science or engineering field and minimum of 10+ years of pharmaceutical laboratory experience required, or Ph.D. in relevant science or engineering field and minimum of 5+ years of biopharmaceutical industry experience required.

  • CMC experience within a development/GMP operations facility.

Skills/Knowledge Required:

  • In-depth knowledge and technical expertise in cell therapy development or drug development.

  • CMC experience within a development/GMP operations facility.

  • Excellent organization, verbal and written communication and presentation skills.

  • Strong interpersonal skills and the ability to work in cross-functional teams effectively and interacting with external collaborators to build strong relationship.

  • Ability to develop and drive project plan and timeline and deliverables to meet overall project goals.

  • Experience with Quality Organization at a Production Center is a big advantage.

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.

Manager CMC, T Cell Science & Technology

Location: Summit, NJ, US

Job ID: 17000945