Celgene Senior Manager, CAR-T Manufacturing Project Management in Warren, New Jersey
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.
The Sr. Manager of CAR-T Manufacturing Project Management reports to the Director of Warren Manufacturing Business Operations and Supply Chain. This role is accountable to manage mid to large scale projects needed for a multi-product clinical manufacturing facility for Celgene Chimeric Antigen Receptor (CAR) T-cell Therapies. This role will matrix manage large cross-functional teams. This role will develop detailed project plans and manage execution of facility and equipment changes for clinical manufacturing of new pipeline products, will lead development of a blueprint plan for best in class clinical manufacturing facility, and will work on operational excellence improvement projects. Work scope will include clinical manufacturing for all cell therapy products, cell therapy technical platforms, and translation plan from clinical to commercial manufacturing. This role will work with other project management and subject matter experts including Manufacturing, Operational Excellence, Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC, TT lead, TCT lead, Global Engineering, Facilities Engineering, IT, EHS, Finance, Regulatory, and Clinical Operations.
This position is based in Warren, NJ. Limited global travel up to 10% of time may be required.
Come join Celgene for this unique opportunity to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies.
Responsibilities will include, but are not limited to the following:
Management of large cross-functional teams
Develop and implement project, risk management, and contingency plans
Develop and implement change execution management strategies to ensure successful project execution
Management and reporting of project budgets
Develop and manage continuous improvement projects
Lead VOC (voice of customer) and VOB (voice of business) surveys as needed
Lead implementation of CAPA projects related to deviation management
Develop executive presentations and reports for project updates
Create and manage project management dashboard, schedules, and risk management plans
Collaborate with project management and subject matter experts including Manufacturing, Operational Excellence, Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC, TT lead, TCT lead, Global Engineering, Facilities Engineering, IT, EHS, Finance, Regulatory, and Clinical Operations
Skill and Knowledge Requirements:
Ability to work independently
Ability to matrix manage large cross functional teams
Ability to manage portfolio of projects that are concurrently ongoing
Ability to rapidly solve problems and deal with organizational complexity
Ability to prioritize and complete work with sense of urgency based on criticality
Ability to interface cross-functionally both internally and externally
Ability to communicate to and present to executive leadership
Demonstrated ability to work as part of a team
High level of interpersonal and communication skills (written and verbal)
Strong knowledge in pharmaceutical development, manufacturing, & supply chain
Knowledge of PDA and ICH Guidelines
High attention to detail skills
High organization skills with ability to multi-task several objectives in parallel
People and project management skills
Customer focused relationship skills
Proficient computer skills with Microsoft Word, Excel, PowerPoint, Project; Visio
Qualifications and Experience Requirements:
Required Bachelor’s Degree in Life Sciences or Engineering
Required Minimum 5 years of experience in pharmaceutical industry (development, supply chain, technical operations, manufacturing, and/or project management)
Required Minimum 3 years of project management experience
Preferred but not required:
Experience in biopharmaceutical clinical, supply chain, manufacturing, and commercialization
Experience with lean six sigma projects and change execution management
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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.