Senior Director, CMC Innovation
2 days ago
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking Senior Director, CMC Innovation as part of the Technical Development team based in Somerset, NJ.
Role Overview
The Senior Director of CMC Innovation will focus on advancing the manufacture and testing of cell therapies along with related treatment modalities via innovative technologies. The successful candidate will lead the identification, development, and implementation of innovation via in-house efforts and company collaborations. He/she will develop business cases to prioritize opportunities based on impact to patient access via improved cost, quality, speed to delivery, and capacity for product manufacture and release. In collaboration with related functions, the Sr Director will lead the implementation across multiple products with appropriate strategy, opportunity, data and regulatory approach.
Key Responsibilities
- Identify and prioritize gaps in the manufacture and analysis of autologous, allogeneic, gene-editing, or viral vector platforms that would benefit from innovative technology.
- Identify innovative solutions with the potential to impact gaps and contribute to continuous improvement of patient access via improved cost, manufacturing capacity, turnaround time, or product quality.
- Create business cases guiding the prioritization and endorsement of development options based on impact, investment, probability of success, timing, and other key factors.
- Develop enabling technologies for emerging product platforms (e.g. bioreactors or rapid potency assays).
- Establish proof of concept for prioritized technologies demonstrating the ability to meet the target technology profile.
- Evaluate the suitability of technology solutions for each Legend product and choose implementation targets.
- Propose an integrated strategy including timelines and cost for implementing new technologies. Align strategy with planned changes in the cell manufacturing process.
- Address necessary implementation needs including procedure generation, equipment qualification, assay validation updates, and regulatory filings.
- Establish strong foundational scientific knowledge supporting the successful implementation of new technologies.
- Collaborate with the business development and associated functions to establish partnerships with key technology partners.
- Maintain strong familiarity with the innovation landscape in the literature, conferences, patents, and companies enabling the harnessing of leading technology.
- Function as a senior staff member of the technical development team, contributing to diversity of perspectives that strengthen the team thought processes.
- Contribute to an empowered, collaborative, science-based, agile, innovative, continuous improvement, and patient-focused culture.
- Maintain strong collaborative relationships among functional areas including a culture of transparency, unity and engagement.
- Direct the support of technical components of CMC sections of regulatory submissions for implemented innovations.
- Direct the creation and execution of strong employee development plans enabling staff readiness for future challenges delivering impactful technologies to patients.
- Provide subject matter expertise on implemented technologies to ensure a smooth transition.
- B.S., M.S., or Ph.D. in biology, biomedical engineering, or equivalent with 10+ years of applied technical experience.
- 15+ years of experience with process/analytical development with exposure to manufacturing and/or QC.
- Deep technical expertise in cell therapy processes and assays.
- Experience with gene editing or viral vector processes and analytics is a plus.
- Strong grasp of comparability approaches.
- Familiarity with the leading technologies for cell processing and analytical methods.
- Working knowledge of analytical method qualification.
- Excellent leadership, emotional intelligence, and communication skills.
- Language(s): English. Mandarin is a plus.
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