Head of Cell Therapy MSAT (Manufacturing Science & Technology) Europe

Job Description

Req #: 1901283
Location: Munich, Germany
Job Category: Technical Development
Work Location: Joseph-Wild-Strasse 20 81829
Organization: Bioengineering
Employee Status: Full-time
Job Type: Regular

This position sits within JUNO THERAPEUTICS (a Celgene company).
Position Summary:
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 Transfers, 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 role will report to the Vice President of Cell Therapy Global Manufacturing Science and Technology (GMSAT) and is a key leadership role within Celgene’s Cell Therapy Development and Operations (CTDO) Division as we get ready to commercialize autologous cellular biologics to overcome tumor evasion and potentially eradicate cancer cells. This head will lead a team consisting of MSAT process engineers based in Europe.
A specific focus of this group will be on accelerating clinical and commercial manufacturing implementation of the next generation CAR T processes, working with the Juno Therapeutics Munich based group. As the head of Munich MSAT team, this head will have decision rights for technical decisions relevant to the commercial implementation of the next generation processes developed by the Juno Munich group. The head works with the MSAT leaders from the Celgene Cell Therapy manufacturing network to ensure CAR T processes follow the network technical standards and meet the commercial manufacturing requirements. This group will lead tech transfers (including assay transfers for some programs) of the next generation CAR T processes from Juno Munich to Celgene cell therapy manufacturing network.
The role will be a member of the MSAT network leadership team and will contribute/influence the cell therapy manufacturing and network strategies and standards for both the viral vector and CAR-T drug product. The head is expected to hire, develop and grow strong technical talent and provide effective technical and people leadership to the Munich MSAT team. The role will work very closely with Drug Product MSAT, Technology groups based in Munich and Seattle, Technical Development, External Manufacturing and Quality and the product life cycle management teams. The head will be a strong technical thought leader in cell and gene therapy field, both internally and externally.
The roles and responsibilities include, but are not limited to, the following:

• Ensure that the commercial manufacturing requirements are communicated to the technology teams and these requirements are incorporated in the next generation CAR T processes.
• Work with external manufacturing to identify CMOs for GMP manufacture of the reagents and critical materials needed for the next generation CAR T processes. Transfer the reagent and critical material processes to the CMOs and provide technical oversight to these CMOs for ongoing supply of reagents and critical materials.
• Successfully transfer next generation CAR-T processes and technology solutions to manufacturing sites in the Celgene network.
• Support, lead process qualification, process control and comparability strategies for the next generation CAR T processes.
• Review/author technical sections of major regulatory documents to introduce next generation CAR T processes into clinic and commercial.
• Work with the CAR T drug product MSAT team to ensure that the next generation CAR T technologies are incorporated in the product life cycle plans.
• Implement continuous process verification strategies in the manufacturing processes for the CAR T reagents and critical materials and these manufacturing processes remain in a state of control and validation.
• Develop commercial process control strategy for the CAR T reagents and critical material processes and implement these strategies at the manufacturing sites (including CMOs).
• Provide technical leadership/support to regulatory/health authority questions for the manufacturing operation (either part of the initial licensure or post approval changes or routine inspections).
• Review, approve validation plans, protocols as appropriate.
• Review, approve sections of the regulatory dossier, briefing books or communications to health authorities.
• Work with process and analytical development to demonstrate comparability upon process changes.

Basic Qualifications

• Bachelor's degree in a life sciences or Chemical Engineering discipline and a minimum of 15 years of relevant experience in biologics development, MSAT or operations.
• 10+ years of direct experience in GMP environment, 7+ years of people management, 5 plus years of experience in cell culture and/or downstream purification.
• Previous experience working in a global environment where interactions spread across multiple sites, locations, functions.
• Demonstrated ability to hire, coach and grow technical talent.
• Experience in product/process CMC life cycle management including pre-launch, launch and post- approval.
• Strong analytical, problem-solving, and critical thinking skills.
• Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent.
• Excellent written and verbal communication skills at all levels in the organization.

Preferred Qualifications

• 2-3 years of experience in cell therapy process development and or manufacturing.
• Combination of experience in process development, MSAT and quality.

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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.