Associate MES Engineer

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.

Legend Biotech is seeking an Associate MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ.

Role Overview

The Associate MES Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for interfacing with MES end users to define change requirements while assisting with EBR development and administration at the Raritan site to support production processing. The associate MES Engineer will liase with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support the MES team with electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS-X).

Key Responsibilities

This individual will be responsible for gaining the necessary process knowledge of the product and system knowledge of PAS-X to develop EBR designs that fit the site’s needs. The major responsibilities will include but are not limited to:

• Work with end users to define MES change requirements
• Support eBR development, modeling, and deployment in MES
• Participate in design testing, release planning, and demos with partners.
• Support MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).
• Support MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ).
• Support updates to standardizations and documentation (e.g. SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.
• Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.
• Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.

This individual is responsible for collecting the necessary information and user requirements to ensure that the MES team properly assesses updates and impact.

Requirements

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• A minimum of 3 years of relevant experience working in a GMP environment is required. Demonstrated experience working cross functionally with multiple departments translating business needs to change requirements. Cell/Gene Therapy cGMP manufacturing and MES (PAS-X) experience preferred.
• Working knowledge of MES application and user experience
• Work cross functionally with stake holders to clearly define business needs
• Accurately and reliably gauge task effort and plan work to meet project timelines
• Work closely with the MES and MSAT organization to ensure translation of changes from concept to implementation.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Provide technical recommendation and limitations associated with MES functionality in the evaluation of potential process changes for effectiveness, value, risk.
• When necessary, support studies related to process improvement and implementation of new manufacturing execution system technologies.
• An ability to build strong partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment.
• Strong analytical, 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.

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The anticipated base pay range is:

$107,482—$141,070 USD

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights 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 - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

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 (including pregnancy, childbirth, or related medical conditions), 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.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.