Celgene Manager, Clinical Supply Chain in Warren, New Jersey
Other Locations: US- NJ- Warren
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, âquest 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.
Major responsibilities include, but are not limited to:
Managing relationships and contracts with specialty couriers and providers of logistics equipment including temperature controlled containers, liquid nitrogen dry shippers, and temperature loggers.
Participating in clinical study team meetings to understand the enrollment projections of ongoing and future studies, prepare a forecast, then consult with manufacturing and supply chain managers to ensure adequate inventory. Provide regular updates to management on inventory levels.
Schedule, maintain, and assign manufacturing slots as appropriate to support patient enrollment.
Maintain accurate clinical site database and contact list. Proactively reach out to confirm collections and receipt of material to allow for any necessary adjustments to the production schedule.
Maintain accurate inventory records and traceability from patient collection to infusion.
Work to improve final product and shipping package configuration to preserve product integrity.
Consult with clinical and regulatory teams to design, translate, and produce compliant labeling.
Assist with development of IRT systems, write and execute user acceptance testing scripts.
Maintain the Trial Master File (TMF) with documentation related to drug release and shipment. Skills/Knowledge Required :
Proven experience with forecast planning, clinical labeling, packaging and cold chain distribution
Working knowledge of drug development process (Phase I-IV).
Working knowledge of cGMPs and familiar with US and EU regulations
Strong analytical and problem solving skills.
Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.
Strong computer, organizational, and management skills.
Knowledge of internal quality systems including Oracle, Celdox, eQRMs, and eRexS Behavioral Competencies:
Proven experience handling confidential information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors is essential and required.
Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
Able to communicate effectively with GPDO functional areas and regulatory agencies.
Promotes an environment of continuous quality and improvement of processes.
Adaptable to dynamic conditions, work practices, and project timelines.
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, Clinical Supply Chain
Location: Warren, NJ, US
Job ID: 1700507