Warren, New Jersey Req #: 1902034
Location: Warren, New Jersey, United States
Job Category: Technical Development
Work Location: 7 Powder Horn Drive 07059
Employee Status: Full-time
Job Type: Regular
This position will be a member of the Global Manufacturing Sciences and Technologies group within the Cell Therapy Development & Operations organization at Celgene. This position has responsibilities that include leading/supporting scale-out, technology transfers, process validation, optimization and continuous improvement activities for new and existing cell therapy products. The position is also responsible for ownership of the process control strategy and providing specialized expertise in support of manufacturing related critical investigations and change control activities.
Responsibilities will include, but are not limited to, the following:
- Own and lead process control strategy to enable seamless and robust Tech Transfer to commercial manufacturing sites, and support commercial drug product manufacturing operations including such as isolation, cell culture, harvest and formulation activities for cellular therapies
- Lead and support technical evaluation of Change Notifications and assist with implementation at multiple sites
- Troubleshoot issues with drug product processing technologies and equipment
- Design of protocols, execution, reporting and approval of qualification and validation reports that support life cycle maintenance
- Develop process and product monitoring plans, master data and documentation management, compliance to Celgene quality systems, and other readiness operational support activities.
- Provide assistance to sites globally to resolve significant quality events and manage complex change controls
- Develop and implement process improvement strategies
- Coordinate internal and external resources to produce empirical data
- Review and co-author sections of the CMC filings
- Foster strong inter-team relationships to achieve common project goals
- B.S., M.S. or Ph.D in Engineering or life science with 8-15 years of relevant technical experience in technical development, manufacturing science or other disciplines in technical operations.
- Strong understanding of bioprocess unit operations, especially cell culture.
- Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.
- Demonstrated experience developing and/or transferring drug products within a pharmaceutical environment.
- Proficient in project management and team leadership skills, with a thorough understanding of critical unit operations involved in drug product manufacturing.
- Experience in technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects.
- Evidence of strong communication skills and of building good relationships with cross functional team members and customers.
- Established scientific professional with track record of technical and cultural leadership and globally-recognized accomplishments that include advancing projects. Influences site and global strategy. Visible contributions to external scientific community, including regulatory settings.
- Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages.
- Strong analytical, problem-solving, and critical thinking skills.
- Sound experience of data handling and applied statistics.
- Experience with Quality Management System (e.g. Deviations, CAPAs, Change Management)
- In managing technical interactions with CMOs, manufacturing of cell therapies, or product life cycle management is highly desirable
About UsCOMMITTED 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.