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.
Reporting to Sr. Director, CAR T CMC Development, this is a Project Management position within the CMC and Clinical Supply subgroup of the Celgene Juno Collaboration team. The primary responsibility of this position is to work collaboratively across the Celgene/Juno/CMO interface with a focus on effective planning, coordination of activities, and efficient implementation of the CMC development and supply strategy.
Specific Responsibilities include, but are not limited to, the following:
•Provide overall project management support to Juno CART CMC and Clinical Supply team in Biologics Development.
•Work collaboratively within Celgene, with Juno and CMO(s) to ensure strong, clear communication to identify and address challenging issues in product development and clinical manufacturing
•Provide project management support to all CAR T supply chain logistics operations, technical transfer and regulatory interaction/submissions.
•Develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities
•Support the team with optimization of plans by evaluating assumptions and incorporation of new inputs as the projects progress through development.
•Facilitate collaborative CMC and supply chain work-stream meetings, both internally, with Juno and with CMOs, using meeting management best practices, and be responsible for efficient conduct and follow through.
•Foster a team culture of ownership and accountability including continuous evaluation, recognition, and process improvement
•Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with CMC project(s) within Celgene/JUNO CAR T collaboration, as well as ensure CMC teams are aware of current integrated program timelines
•Coordinate preparation and review of CMC regulatory filings
•Organize and oversee preparation and execution of contracts, work orders and invoices. Ensure timely completion
•Prepare Juno CAR T project budgets and track expenditure. Interface with FP&A staff for monthly reporting and forecasting.
•Lead resource planning and mapping for Juno CAR T CMC project and workforce planning.
•MS or Ph.D in a biotechnology discipline, with 10+ years of relevant pharmaceutical product development experience. Experience in analytical development, process development, and manufacturing of biologics/cell & gene therapy preferred.
•Certificate of Project Management
•5+ years of Project Management at a fast-paced, innovative biotech/pharma company.
•Prior experience managing cross functional teams with timeline management and budgetary responsibility
•Excellent project integration, planning, communication and documentation skills. Familiarity with planning tools.
•Expert knowledge of MS Project, MS Visio and MS Excel
•Exceptional verbal/written communication, presentation, time/resource management, attention to detail, interpersonal and organization skills
•Demonstrated ability to work in teams, to build strong relationships and to lead by influence
•High energy level, personal productivity, creativity and commitment.
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.