Senior Director, External MSAT

Celgene   •  

Seattle, WA

Industry: Pharmaceuticals & Biotech

  •  

15+ years

Posted 62 days ago

This job is no longer available.

POSITION

Head of External MSAT

SUPERVISOR


VP, Cell Therapy Global MSAT

DEPARTMENT

Cell Therapy Global MSAT

PREREQUISITES

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


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. 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:

  • Participate in the CMO and raw material supplier selection process by evaluating CMO/supplier technical capabilities against cell therapy manufacturing requirements
  • Ensure routine technical support of the CMOs for deviation management, lot disposition, batch record reviews to ensure that technical issues stay off the critical path for reliable supply
  • Participate in the appropriate internal and joint CMO governance meetings (ex, joint steering committees)
  • Provide technical support for network wide technical issues that touch or impact the CMO operation
  • Ensure the CMC life cycle strategies for the product are implemented at the CMOs to maintain manufacturing process is harmonized at all the sites
  • Ensure the manufacturing process at the CMOs is in a state of validation at all times
  • Implement CPV (Continuous Process Verification) at the CMOs
  • Ensure raw material changes initiated by the vendor are appropriately responded to based on technical assessment. Ensure that the technical changes for the raw materials are coordinated across the network
  • Develop mitigation plans for significant technical risks at the CMOs or key raw material suppliers
  • Execute tech transfers in and out of CMOs in a manner consistent with our network practices appropriately accounting for the CMO capabilities and requirements
  • Provide technical leadership/support to regulatory/health authority questions for the CMO 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
  • Ensure that MSAT role in the CMO virtual plant teams is aligned across CMOs to ensure proper calibration of CMO oversight practices
  • Develop risk based strategies for the CMO technical oversight taking into account the prodict lif cycle, technical complexity and CMO capabilities.


Basic Qualifications

  • Bachelor's degree in a life sciences or Chemical Engineering discipline and a minimum of 15 years of relevant biotechnology or pharmaceutical industry (operations, technical development, MSAT)
  • 10+ years of direct experience in GMP environment and 7+ years of people management
  • Previous experience leading global teams in multiple locations
  • Previous experience in technical oversight of CMOs and suppliers
  • Demonstrated ability to hire, coach and grow technical talent
  • Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages
  • Strong analytical, problem-solving, and critical thinking skills
  • Experience with Quality Management System (e.g. Deviations, CAPAs, Change Management)
  • 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.