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 Manager – Cell Therapy
Instil Bio UK is now recruiting a Manufacturing Manager, responsible for supporting the Director of Manufacturing (UK) in building, training, managing and mentoring manufacturing staff within the Manufacturing function at Instil Bio (UK)’s clinical manufacturing facilities in Manchester, UK. You will be responsible for leading, developing and managing staff to manufacture batches to meet clinical demand, achieve improvements in planned aseptic manufacturing production, pharmaceutical awareness, cGMP, capacity utilisation, quality, cost and supply plans and activities in compliance with company, regulatory, pharmaceutical standards.
As the Manufacturing Manager you will be required to:
• Support the Dir. Of Manufacturing in strategic planning and leadership to meet site and global objectives.
• To recruit, train, develop and coach technical team members such that increased focus is put on pharmaceutical awareness and operating standards as well as job skills and knowledge 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
• Through implementation of Continuous Improvement philosophy, manage and improve pharmaceutical standards, awareness & compliance within the technical team (measures: CAPA close out, NCR close out, clean room standards, engineering standards);
• 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
The role is not required to be on a shift pattern but will require establishing multiple teams and shifts to deliver product through clinical trial according to targets. Flexibility may be required to take calls or do some work from home outside normal business hours.
Relevant Education Skills and Experience
This role will involve hiring and building teams along with team management. It will involve developing and leading other manufacturing and manufacturing support staff. To be successful it is anticipated you will have gained the following skills, traits, and experience:
• Team management and people development. Ability to successful manage manufacturing operations through good planning and resourcing. Eye for detail to ensure right first-time operational excellence.
• At least 5 years of experience managing operational teams Managing at least 12 staff. Experience of implementing strategic decisions through organised teams. Experience representing manufacturing on large multi-disciplinary project teams 10+ years relevant GMP aseptic cell culture manufacturing experience (e.g. cell therapy, gene therapy, biologics, vaccine)
• BS degree in life sciences, engineering or related field, advanced degree, e.g. MS, MBA, and/or PhD preferred Quality Systems used in GMP environments Knowledge of GMPs and compliance within the biopharmaceutical industry
• A target driven team builder who enjoys working in a fast-paced environment
• Detailed planning and resource management Very good communication and interpersonal motivation skills Ability to accommodate flexible working hours depending on work nee
The following experience may be considered an advantage but is by no means essential to a successful application:
• Guidance and compliance with MHRA, HTA, European Directives or FDA guidance for Cell Therapies
• Experience in cell therapies/ATMPs
• Experience with managing shift working
Remuneration & Benefits
The salary for the Manufacturing Manager 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. In any event we anticipate a salary in the £45,000 to £55,000 range together with an attractive bonus and benefits package.
If you would like to join us as Manufacturing Manager 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.