Operations Lead Support Specialist

Summary: Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. They are seeking an Operations Lead Support Specialist to join their Technical Operations team, responsible for the production of personalized cell therapies in a sterile cGMP environment. Responsibilities: - Support process unit operations (i.e. cell culture, purification, aseptic processing, and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, concise format - Ensure the team performs tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements - Build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional team to complete production tasks required by shift schedule - Demonstrate a mastery of all process systems (MES, SAP/S4, eLims, etc) , workflows, and equipment related to production support - First line of support for Production Support Operators to resolve issues and answer questions on the production floor - Utilize Leadership Standard Work and Process Confirmation practices to set the team up for success - Support the development of manufacturing processes, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations Required Qualifications: - Bachelor's degree in engineering or related field or equivalent experience required - A minimum of 1.5-3 years of operations experience within a cGMP environment in the biotech/biopharma industry - An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment - Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively - Ability to lead small teams and direct Operators on daily tasks - Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures - Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products - Ability to lift a minimum of 50 lbs and stand for a long period of time - Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records - Ability to handle human derived materials in BSL-2 cleanroom facility - Physical dexterity sufficient to use computers and documentation - Ability to accommodate shift work including evenings and weekends as required by the manufacturing process - Ability to accommodate unplanned overtime on little to no prior notice Required Skills: cGMP environment experience, cell culture, purification, aseptic processing Important Skills: process improvement, leadership skills, communication skills, cross-functional collaboration Nice-to-Have Skills: Bachelor’s degree, FDA guidance knowledge, lift 50 lbs, physical dexterity Benefits: Medical, dental, and vision insurance, 401(k) retirement plan with a company match that vests fully on day one, Eight (8) weeks of paid parental leave after just three (3) months of employment, Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays, Flexible spending and health savings accounts, Life and AD&D insurance, Short- and long-term disability coverage, Legal assistance, Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance, Voluntary commuter benefits, Family planning and care resources, Well-being initiatives, Peer-to-peer recognition programs