Head of External MSAT
VP, Cell Therapy Global MSAT
Cell Therapy Global MSAT
Bachelor's or Graduate degree in Chemical Engineering or Life Sciences with >15 years of experience in Biotech industry, at least 5 years of experience in technical oversight of external operations and GMP environment
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. Reporting to the Vice President of Cell Therapy Global Manufacturing Science and Technology Head of global validation is a key leadership role within Celgene's Cell Therapy Development and Operations (CTDO) Division.
This senior leadership role will lead a global team consisting of MSAT process engineers and people managers that is responsible for technical oversight of the CMOs (contract manufacturing operations) and key suppliers within the Celgene cell therapy manufacturing network. The scope of the role includes CMOs for the CAR-T drug product operations across the world, suppliers of key raw materials for the drug product and viral vector manufacturing processes throughout the product /process life cycle stages. The scope will evolve along the product life cycle stages from manufacturing/operations support of the CMO during clinical production to technical stewardship pf the manufacturing process starting with the performance qualification stages and beyond. As such, this team will have responsibilities like an internal MSAT organization for any of Celgene's cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMOs or suppliers. The head will be part of the global MSAT leadership team and the MSAT network governance team to ensure that the technical standards and manufacturing requirements at the CMOs are comparable to the internal standards and our manufacturing processes are harmonized across the overall manufacturing network. The head will be accountable to ensure that the technical initiatives in the MSAT network (such as process monitoring, data integration, establishments of network standards, implementation of new technology into the manufacturing sites, etc.) appropriately include the CMOs. This team will be responsible for tech transfers of new processes and process improvements to the CMOs and transfer from the CMO to the internal site. The head will ensure that the team works with the other MSAT groups, technical development and quality to make sure that life cycle process improvements are implemented in a harmonized and planful manner at the CMOs. The head will partner with the heads of external operations in Supply chain and quality organization to ensure a coordinated and efficient oversight of the CMOs, aligned short term project plans and mid/long term external operations strategy and proactively define the corresponding technical strategy. The head will actively participate in all stages of CMO management (from selection to operationalization to divestment) and ensure that the CMO strategy, capabilities are used as an input into our internal technical strategy and equally importantly the CMOs are capable to meet our technical requirements. With respect to suppliers of key raw materials, the head will work with other functions in CTDO to ensure raw materials meet the technical requirements for manufacturing and support vendor audits and management processes and ensure appropriate mitigations are in place for ensuring uninterrupted quality supply of key raw materials (including dual sourcing). The head will recruit and develop technical talent within external MSAT and ensure that the external MSAT team is fully integrated in the network MSAT initiatives. The head is expected to work closely with the cross functional counterparts in supply chain and quality to ensure that we develop an effective relationship with the CMOs and suppliers.
The roles and responsibilities include, but are not limited to, the following: