Company Information 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 Risk Assessment Specialist as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible for leading and facilitating Risk Assessment Projects to the cGMP Clinical and Commercial Cell Therapy Manufacturing Plant. In addition, the candidate must have Quality Risk Assessment experience in the pharmaceutical industry. Primary responsibilities include, but not limited to, managing activities leading to the successful execution of the risk assessment; establishing Risk Assessment plans with milestones and deliverables in collaboration with stakeholders (Quality, production, engineering, QC and process improvement and R&D etc.); conducting risk assessments; and ensuring accountability of team members for deliverables. Additionally, the Risk Assessment lead will communicate across functional and leadership levels to inform all risk assessment status, as well as elevate issues, present recommendations and implement modifications to risk assessment plans. Key Responsibilities
- Follow QRM (Quality Risk Management) process per ICH Q9, identify the risk, analyze the risk, evaluate the risks and work resources to control the risks based on failure analysis results
- Plan and implement Risk Assessment, support define Risk Assessment scope, goals, deliverables; and define tasks and required resources
- Serve as leader and prime advocate for your Risk Assessment, design, manage, support and direct risk assessment team
- Manage stakeholders, create schedule and risk assessment timelines, track deliverables and monitor and report on risk assessment progress
- Present to leaders reports on progress as well as problems and solutions, and implement and manage change when necessary to meet risk assessment outputs
- Lead issue oriented Risk Assessment meetings; mediate and resolve conflicts; and drive teams to success.
- Follow-up on action items between team meetings and ensure accountability of team members.
- Interface with all levels of management and ensure alignment throughout the organization.
- Be a model of superb organization, excellent timeliness and tireless follow up.
Requirements
- BS/BA required in technical discipline: Engineering, science or similar field
- Pharmaceutical/Life Sciences project management professional plus a minimum of 1 year of project management experience in the pharmaceutical industry with Project Management Professional (PMP) certification or equivalent is desirable.
- Understanding of manufacturing processes and quality risks, and experience in pharmaceutical GMP Manufacturing Operations is a plus.
- Proficiency in MS Office, MS Project and other project management tools.
- Strong analytical skills and business acumen.
- Cross functional collaboration skills with the ability to network with different functional areas and integrate cross functional deliverables.
- Strong oral interpersonal and written communications skills.
- Must have an experience in risk assessment tools (e.g. FMEA, FTA, Pareto analysis, HAZOP, HACCP)
- Project Management or quality or manufacturing background
- Ability to engage all levels of the organization, from site leadership to the shop floor
- Proven experience working and leading in a matrix environment
- Ability to lead with influence
- Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
- Strong analytical, problem solving and critical thinking skills
- Change management
- Excellent organizational and communication skills
#Li-JT1 #Li-Hybrid 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 law. Legend Biotech maintains a drug-free workplace.