Job Description: Req #: 1900813
Location: Warren, New Jersey, United States
Job Category: Technical Development
Work Location: 7 Powder Horn Drive 07059
Employee Status: Full-time
Job Type: Regular
Celgene is seeking a Compliance Manager for Clinical Cellular Therapeutics Manufacturing. The Manager will partner with Manufacturing Leadership and Site Quality to support all aspects of compliance and quality for Manufacturing Operations. This person will be a key leader responsible for GMP operations and meeting critical business goals.
Establishes and manages the Celgene Warren Manufacturing Compliance team. This includes: hiring, mentoring and developing exceptional people
Championing a culture of exceptional teamwork and communication across the organization
Ensuring people have the appropriate level of training
Building effective cross-functional relationships
Ensuring a culture that embraces the safety of the work environment and the safety of the
patients by compliance with company procedures and policies, and cGMP requirements
Establishing department goals, tracking and reporting KPIs, and driving continuous improvement efforts
Designing and operating manufacturing systems that are technically sound, promoting effective and efficient operations, and complying with cGMP requirements
Owning master batch records for cell therapy processes and ensuring revisions meet compliance and scientific needs
Owning and approving routine deviations for the manufacturing department and ensuring on time closure
Defining and implementing effective CAPAs to improve compliance and manufacturing success
Becoming point of contact in manufacturing for change controls
Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients
Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports
Bachelors / Masters in relevant science or engineering discipline
8+ years of experience in cGMP biologics manufacturing, experience in Quality Assurance or Regulatory preferred. Further preference given to Cell Therapy experience as well.
2+ years supervising staff in a management role
Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
Demonstrated ability to hire top talent
Demonstrated experience building and leading exceptional teams
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.