Director Of Manufacturing Execution System

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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

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). 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.

The Director of Manufacturing Execution System (MES) will be part of Manufacturing Science and Technology (MSAT) Leadership Team and will be responsible for the development of a best-in-class MES organization at the Raritan site while advancing a global CAR-T MES organization across the Legend network. This role will establish technical and governance leadership while establishing the priorities of the MES organization. Role will work collaboratively with Operations, IT QA, Validation, Reg CMC to deliver on-time, on-budget and right-first-time MES solutions for the organization. This individual will ensure electronic batch records (EBRs) and associated log books, forms, etc can be updated quickly and leverage network capabilities to avoid duplication of efforts across sites.

Key responsibilities include:

• Managing the current MES system that drives ongoing manufacturing and system upgrade/improvement projects.
• Implementing a continuous improvement program to leverage network capabilities that ensure EBR's and log books are being updated quickly and to avoid duplication of efforts across sites.
• Applying and teaching change management methodology in all aspects of the plant operational excellence efforts.
• Identifying, developing, and implementing system improvements for local MES system.
• Aligning global process strategy and data governance initiatives.
• Ensuring audit readiness and support.
• Responsible for the site system strategy and managing the interdependence with site's base business.
• Overseeing the hiring, development, and performance management of MES team.
• Establishing key stakeholder relationships with internal and external stakeholders.

Requirements include:

• A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• A minimum of 12 years of relevant experience.
• Demonstrated experience leading MES team(s) and translating business needs to system requirements.
• Cell/Gene Therapy cGMP manufacturing and supervisory experience preferred.
• Alternate experiences delivering complex IT systems could be considered.
• Ability to build high performing site based MES teams.
• Work closely with MES teams across sites to harmonize across the network to allow leveraging of designed and speed of implementation.
• Work closely with the development and MS&T organization to ensure suitable translation of changes from concept to implementation, building long term implementation and support plans.
• Build strong teams that are able to manage changes from ideation at the non-conformation investigation change thought design and implementation. This involved cross collaboration of team with multiple organization particularly investigations, manufacturing, technical support and QA.
• Ensure MES team can prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Enable MES team to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Develop team to provide technical recommendation and identify limitations associated with MES functionality in the evaluation of potential process changes for effectiveness, value, risk, and priority.
• Ensure the MES team drives the implementation of MES enhancements that would provide reduction in COGs, and increase throughput, capacity, and quality compliance.
• Work cross-functionally across the organization and interface with IT to drive the design and implementation of new system updates for cell therapy development and manufacturing.
• An ability to build strong partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment.
• Strong problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Clear and succinct verbal and written communication skills.

The anticipated base pay range is:

$163,468 - $214,551 USD

Benefits include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.