Celgene Associate Manager, CMC CAR-T in Warren, New Jersey

Other Locations: US- NJ- Warren

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.

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 Summary: 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 in order to support CAR-T global clinical trials and advance rapid commercialization of CAR-T therapies. Responsibilities will include, but are not limited to, the following: •Review manufacturing batch records and product associated documents for clinical CAR-T product release partnering with QA. •Review analytical data for clinical CAR-T product release. •Manage deviations/OOS/CAPA in Celgene compliance system for clinical CAR-T product release. •Generate Certificate of Analysis (CoA) for CAR-T clinical product release. •Manage change control through impact assessments, tracking and implementation. •Tracks and reports performance metrics as required. •Interface with contract manufacturers and testing laboratories to communicate and promptly resolve product issues. •Manage all project-related documentation (all SOPs, important technical reports, etc.) in Celgene’s documentation system and manage the version change. •Provide necessary technical support to Celgene Quality Operations (quality document review, audit support, risk assessment, etc.) •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. #LI-POST

Prerequisite: BS in relevant science or engineering field with minimum of 8+ years of pharmaceutical experience or MS with minimum of 6+ years of pharmaceutical experience required. Skills/Knowledge Required: •Knowledge and technical expertise in cell therapy development or drug development. •CMC experience within a development/GMP operations facility. •Knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance. •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. •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.

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.

Associate Manager, CMC CAR-T

Location: Warren, NJ, US

Job ID: 17001794