Instil Bio (UK)
About Instil Bio
Instil Bio is a cell therapy company developing tumor infiltrating lymphocytes (TIL) for the treatment of solid tumor cancers. TIL are a patient’s own T cells harvested from the patient’s tumor, which are then expanded and reinfused into the patient to target and kill cancer cells. Instil is advancing its proprietary TIL manufacturing expertise, technology, and data into clinical trials, including a planned registrational study with its lead candidate and a first-in-human study of its next-generation engineered TIL. The company is led by world-class cell therapy experts and backed by premier global institutional investors.
Instil Bio UK is Instil’s rapidly-growing, Manchester UK-based subsidiary. Our Manchester subsidiary has significant R&D, process development, and clinical manufacturing capabilities, with approximately 35 staff expanding to > 100 staff. Instil Bio UK has been generating cell therapy products for patient use since 2011, including TIL products and external partner genetically engineered T cell products.
Manufacturing Director – Cell Therapy
Instil Bio is seeking a driven and experienced Manufacturing Director – Cell Therapy to report to the Head of Cell Therapy Production. This individual will have multiple production managers as direct reports. The manufacturing team is rapidly growing and this role will establish multiple teams and shifts to deliver engineered cell therapy products in Phase 1 and pivotal clinical trials. The candidates must be knowledgeable of aseptic cell culture manufacturing processes and able to work in a dynamic start-up environment to bring a life-saving cell therapy product to patients.
– Provide strategic and day to day leadership for the GMP Production function
– Hire manufacturing staff; ensure they are trained and adhere to procedures and policies governing GMP manufacturing of an advanced therapy medicinal product (ATMP)
– Ensure manufacturing operations adhere to regulatory requirements (US, UK, and EU)
– Work with QC and QA to ensure on-time product release per specification
– Work with supply chain to plan production schedules, receive material and execute on-time product manufacturing
– Implement operational excellence principles to ensure accelerating manufacturing cadence meets clinical targets
– Setting, communicating, tracking and reporting KPI’s at a personal and departmental level
– Champion a continuous improvement culture; work cross-functionally with Manufacturing Sciences and Technology (MS&T) and Quality to improve manufacturing operations in a compliant manner
– Work cross-functionally on new product introduction and process changes (transfers, improvements, validation)
– Ensure processes are followed for change controls, deviations/investigations, CAPAs, process transfers, validations, risk analysis, and mitigations
– BS degree in life sciences, engineering or related field, advanced degree, e.g. MS, MBA and/or PhD preferred
– 10+ years relevant GMP aseptic cell culture manufacturing experience (e.g. cell therapy, gene therapy, biologics, vaccine)
– At least 4 years of experience managing operational teams
— Managing at least 15 staff
— Experience developing, justifying and implementing strategic decisions
– Extensive exposure to Quality Systems used in GxP environments complying with MHRA, HTA, European Directives or FDA guidance for Cell Therapies
– Experience representing manufacturing on large multi-disciplinary project teams
– It is advantageous if you have experience with facility start-up and technology transfer
Remuneration & Benefits
The salary for the Manufacturing Director – Cell Therapy will be competitive within the Biotechnology and wider scientific sector with actual salary offered reflecting relevant qualifications and experience as well as performance at interview.
If you would like to join us as a Manufacturing Director – Cell Therapy at this critical time in our development and you think your skills and experience are a good fit for this role, apply with a current CV and we’ll get back to you within a day or two…… click apply for full job details
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