Car T Vector Technical Steward
Req #: 1900822
Location: Warren, New Jersey, United States
Job Category: Technical Development
Work Location: 7 Powder Horn Drive 07059
Employee Status: Full-time
Job Type: Regular
Come and join Celgene for this key leadership role to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies. At Celgene, we are developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer.
Cell Therapy Global Manufacturing Science and Technology (GMSAT) plays a critical role in Technology Transfer, CMC life cycle management, establishing manufacturing standards, process engineering, process validation, technical oversight of external manufacturing partners and product/process capability to enable a robust and scaleable, global cell therapy manufacturing network. This position provides technical and process leadership and oversight to the viral vector manufacturing process from pivotal process to post-approval stages. The role would also support pre-pivotal technical development activities specifically with respect to tech transfers to external or internal manufacturing sites. This is a key technical role within Celgene and Juno's cell therapy technical operations division as we get ready to commercialize autologous cellular biologics to overcome tumor evasion and potentially eradicating cancer cells. This role will assume primary technical leadership for the manufacturing process for the viral vectors used for the assigned CAR T programs. This includes establishing the requirements for the commercial manufacturing process, transferring vector manufacturing process across the network (internal sites and CMOs), developing process qualification, process control and comparability strategies, authoring technical sections of major regulatory documents and contributing to the overall CMC strategy of the current vector technologies and future gene editing technology. The role will serve as a single point of technical contact for the vector technology in scope and will be the decision maker on key issues related to manufacturing process. The scope of the role includes providing ongoing technical oversight to internal and external manufacturing, defining and driving a long-term process improvement lifecycle plan and ensuring successful execution of the technical strategy. The role will work cross-functionally across technical operations and most closely with process and analytical development, quality, regulatory, manufacturing and supply chain counterparts. The role may assume supervisory responsibility for junior technical team. This role will be a member of the Cell therapy CMC teams, external manufacturing oversight teams and also lead the technical team staff to coordinate multiple projects across the product in scope. The incumbent will help drive the validation, qualification and comparability strategies and be viewed as a technical thought leader internally and externally in viral vector manufacturing technology.
Major job duties include:
- Provide technical leadership to ongoing manufacturing process issues at internal and external sites, investigations, unexpected process behavior.
- Develop tech transfer strategy and lead cross functional technical teams to ensure successful and timely execution of the tech transfers
- Develop product technical strategies including manufacturing requirements, process improvement plans, post approval life cycle management plans and ensure successful and timely execution working across functionals.
- Provide technical content for significant inspectable documents such as PPQ or comparability assessments, author content for regulatory submissions, present technical strategies during major health authority interactions and inspections.
- Perform and support data monitoring of manufacturing processes to understand process capability and troubleshoot investigation-driven events
- Function as a subject matter expert for autologous T cell therapies and viral vector process and technology
- Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
- Serve as a mentor to staff in the technical teams
- Present complex technical topics internally and externally
- Author, review, and approve tech transfer and process documentation to support initial and continued manufacturing and internal and external manufacturing sites. As needed and when significant technical issues arise, the role is expected to be hands-on in nature for troubleshooting and manufacturing support.
- B.S., M.S. or Ph.D in Engineering or life science with 10-15 years of relevant technical experience in technical development, manufacturing science or other disciplines in technical operations (including experience in GMP environment)
- Excellent written and verbal communication skills. Ability to wrote and present complex technical issues to diverse audience internally across technical operations and externally to manufacturing partners and health authorities
- An 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. Strong leader of others.
- Effective leader of cross-functional technical teams with broad scope
- Works on new or complex problems requiring analysis of multiple factors and data sources, in-depth evaluation of variables, and independent decision making.
- Exercises sound, independent judgement when making decisions and proposing solutions to new or complex problems, balancing short and long-term deliverables.
- Successfully resolves a variety of ambiguous situations.
- Participates in department level strategic planning and prioritization. Provides input for decisions on operational matters and plans to achieve objectives.
- Impacts initiatives across departments and regularly partners with external stakeholders.
- This role requires upto 35% travel to global manufacturing sites and CMOs, Role preferred to be based in Seattle, WA but can be in Summit, NJ
- In managing technical interactions with CMOs, previous experience in technical development/manufacturing of viral vector processes and product life cycle management is highly desirable
- Previous experience in managing direct technical staff is highly desirable.
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.