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. This role will report to the Vice President of Cell Therapy Global Manufacturing Science and Technology, the Head of global validation is a key leadership role within Celgene's Cell Therapy Development and Operations (CTDO) Division. Reporting to this role will be the Head of process validation, Head of equipment validation and other validation subject matter experts. Role will also have a dotted line oversight of validation activities managed by the local MSAT validation leads to ensure harmonized approach.
This senior leadership role will lead validation programs across the entire manufacturing network in CTDO (Cell Therapy Development and Operations) covering process, equipment and various supporting elements of manufacturing validation. The scope will range across all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for the plasmid, viral vector and drug product. The process responsibilities include developing process validation standards, process qualification strategy and framework for cell therapy processes, continuous process verification (CPV) strategy and implementation in a consistent manner across products and sites. The equipment validation responsibilities include developing validation standards, framework for harmonized validation strategies for similar equipment and unit operations across plants and IQ and OQ activities during the commissioning stages of new equipment. This team will also support validation activities needed during design and build of new manufacturing plants to make sure the engineering approaches consider our harmonized validation framework that is complaint with the global health authority expectations and scientifically sound. This leader is expected to work across various CTDO functions, internal and external manufacturing sites and collaborate closely with local MSAT validation groups, quality and regulatory functions to shape the process, equipment and validation program and policies that are harmonized and defendable with the global health authorities. Furthermore, the head of validation will interface with the validation counterparts in the Celgene Biologics and small molecule network to leverage expertise and knowledge across modalities. Candidate is expected to participate and network in the external industry forums and conferences to influence and contribute to the evolution of cell therapy manufacturing and validation practices. The head will develop a team of technical experts who understand the cell therapy manufacturing process to develop fit for purpose and scientifically sound validation strategies. In addition to developing strategies and standards, the team will participate in execution activities across the network to ensure expertise is integrated within the different work centers and our validation standards and master plans represent the continuous learning from the manufacturing experience.
Major job duties include:
- Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry practices for cell therapy.
- Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to cell therapy production.
- Lead, develop and implement the master validation plans for process, equipment and facilities, in collaboration with the validation and technical SME network.
- Develop and guide process validation, qualification and process monitoring strategies and framework.
- Guide the teams to storyboard and present Celgene's global validation framework, standards and approaches during major health authority inspections.
- Shape and review the technical content in the validation sections of the dossier
- Support Quality and IT for validation of computer systems, as needed
- Provide validation expertise for issue resolutions to support deviations or CAPAs. and audit findings
- Develop/approve cGMP documents including, but not limited to, Master Validation Plans, protocols.
- Collaborate with QA to monitor and respond to audit observations related to GXP regulations
- Work with MSAT network, to assess impact of changes to facility/processes validated state
- Mentor a team of validation engineers and professionals and enable their individual growth
- Establish performance goals and strategic/operational objectives for direct reports
- Track department performance metrics and provide progress reports to stakeholders
- Lead global validation team providing oversight of internal programs and with direct responsibility for validation activities at contract manufacturing organizations, including validation gaps assessments during CMO selection and tech transfers
- Provide oversight via review and approval of network site level deliverables, including Validation Master Plans, process validation protocols and risk assessments.
- Design qualification strategies to support novel applications of fill, filtration, sterilization and single-use disposable technologies
- Facilitate harmonization amongst sites and adoption of industry best practices
- Partner with Quality Assurance to maintain high standard of compliance in all program deliverables.
- Work closely with process and analytical development and MSAT network during process characterization and validation stages of the late stage development to ensure that the process validation framework is consistent with our overall strategy
- 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 validation activities, and 7+ years of people management
- Proven record with successfully managing validation programs in support of GMP operations
- Experience leading regulatory inspections regarding validation
- Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations
- 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
- 2-3 years of experience in cell therapy process development and or manufacturing.
- Combination of experience in process development, MSAT and quality.