Manufacturing 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 Manufacturing Engineer, Strategic Initiatives as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

The Manufacturing Engineer, Strategic Initiatives is an exempt level position working within the Site Strategic Initiatives team. This role will specialize in manufacturing process optimization and provide dedicated engineering expertise related to new process/technology integration and facility expansion initiatives.

Key Responsibilities  

• This individual’s primary responsibility will be support of manufacturing process optimization through process modelling, new technology integration, and various site expansion initiatives.
  
• Establish relationships and work cross functionally with local and global stakeholders including but not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality.
  
• Work closely with Sr. Manager, Strategic Initiatives to support various strategic initiatives focusing on site expansion and evolution of the manufacturing facility.
  
• Establish expertise on site manufacturing processes to effectively support the process improvements and new technology integration, while ensuring alignment with site capacity goals.
  
• Display critical thinking skills to independently evaluate manufacturing process/facility limitations, to effectively assess and support novel solutions.
  
• Analyze the manufacturing process to identify areas of inefficiency and develop novel solutions to optimize the manufacturing process.
  
• Own/support development of site operational models to better understand and assess resource utilization, equipment utilization, change impact, etc.
  
• Support assessment of facility fitness, and design of facility upgrades to support integration of new technology.
  
• Ensure project deliverables are executed in an effective, efficient, and compliant manner.
  
• Participate in Risk Assessments, FMEAs, and system/data process mapping activities.
  
• Execute, own, assess and participate in the creation, revision and review of change controls, SOPs, and other documentation.
  

Requirements

• Bachelor’s degree in Engineering, related field, or equivalent experience is required.
• A minimum of 6 years of within a cGMP environment in the biotech/biopharma industry is required.
  
• A minimum of 4 years of cell therapy experience is preferred.
  
• A minimum of 3 years of engineering experience is required.
  
• A minimum of 2 years of tech transfer experience is preferred.
  
• A minimum of 2 years of facility/process qualification experience is preferred.
  
• A minimum of 2 years of commissioning/qualification experience is preferred.
• Background in a heavily regulated pharmaceutical environment with adherence to strict regulatory guidelines and internal compliance policies.
  
• In depth understanding of cleanroom manufacturing, aseptic manufacturing processes, and common challenges.
  
• Must exhibit strong Leadership skills and ability to effectively communicate with a wide variety of stakeholders across the organization.
  
• 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.
  
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
  
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
  
• Ability to tailor communication to convey detailed information to a wide variety of audiences.
  
• Strong technical writing skills to author manufacturing SOP’s or technical documentation as needed.
  
• Experience with process modelling and optimization.
  
• Experience with new facility design or design of existing facility upgrades.
  
• Experience with new facility startup or new equipment/technology set up.
  
• Experience with equipment, facility, and process qualification activities including, but not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.
  
• Experience with change management/change control and quality systems.
  
• Experience with FMEA and risk assessment tools.
  
• Experience with user requirement documentation and factory/site acceptance testing.
  
• Experience interfacing with vendors to assess novel equipment or technology.
  
• Experience with tech transfer at early and mature stages of technology development.
  
• Thorough knowledge of regulatory requirements such as 21 CFR Parts 210, 211, 11, EU Annex 11.

#Li-BZ1

#Li-Hybrid

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.