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.
#Li-Onsite
#Li-RN1
The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.
Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary 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 voluntary 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.
Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
Legend Biotech Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Legend Biotech and has not been reviewed or approved by Legend Biotech.
-
Fair & Transparent Compensation — Pay is considered competitive for many roles, with base rates often described as good or above local industry averages. Feedback suggests posted figures for titles like Specialist, Scientist, and certain HR roles sit above common national benchmarks.
-
Retirement Support — A 401(k) company match that vests on day one is repeatedly highlighted as a standout element. Immediate vesting increases the tangible value of the retirement offering from the start of employment.
-
Leave & Time Off Breadth — PTO structures commonly include vacation, personal, sick time, floating holidays, and around 11 company holidays. Several postings outline clear day allocations, signaling breadth and clarity in time-off design.
Legend Biotech Insights
Similar Jobs
What We Do
Legend Biotech is a global, commercial-stage biotechnology company developing and manufacturing novel therapies. We explore and apply innovative technologies to deliver cutting-edge options for patients around the world. Our corporate headquarters is located in Somerset, NJ, and our manufacturing footprint includes facilities in the United States, China and the Belgium.
