Senior Programme Manager – Cell Therapy

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.

Senior Programme Manager

We now have a great opportunity for a Senior Programme Manager to join the team at a critical phase of our growth.

The programme management team are responsible for interacting cross functionally with the key stakeholders for the operational side of the business including: Manufacturing, Quality, Process Development, MSAT, Analytical Development, and Supply Chain functions. In addition, with large build and renovation projects underway they manage construction company and contractor  relationships.

Key Responsibilities & Deliverables

As the Senior Programme Manager, reporting to the US based Director of Programme Management, you will manage a cross functional team for facility and clinical manufacturing with the over-arching objective to:

[1] enable and maintain facility licensure by the MHRA & HTA 

[2] support IND/CTA submissions 

[3] support capacity management

This will involve working with:

  • Process Development, Manufacturing and Quality groups to drive process transfer, personnel training, GMP readiness.
  • Quality to drive quality approved documentation relating to new facility, inclusive of SOPs, BMR revisions, safety procedures/protocols, staff entry/egress, material movement, warehouse management, etc.
  • Manufacturing, Quality and Regulatory to enable licensure amendments for the GMP facility and inspection preparation.

And you will:

  • Develop, drive, monitor, refine project plans/timelines for the building renovation and subsequent activities to support facility licensure, regulatory submissions, and clinical trial material (CTM) manufacturing ramp up.
  • Organize, facilitate, document and manage efficient, action-oriented operational readiness team meetings, following tasks up to ensure completion consistent with the company’s operating model.
  • Anticipate and identify functional area issues and risks, work with team members to document and resolve issues, leads scenario planning exercises, and develop risk management plans as needed for project.
  • Coordinate effective team communications and information flow to relevant stakeholders including within the company in the UK and US, and with external partners
  • Provide status updates to Technical Operations and PM leadership by utilizing functional area dashboard and other complimentary methods.
  • Work to ensure effective Tech Ops Teams and Sub teams, developing and maintaining high performing team environment
  • Mentor, train and support staff in phased appropriate project management activities

Relevant Skills & Experience

In order to be successful as a Senior Programme Manager you will have a strong CMC background with subject matter expertise in either Process, Manufacturing or Quality functions. You must have a solid understanding of overall drug development processes, especially from a CMC perspective. Prior experience of cell therapy or biopharmaceutical CMC is strongly preferred.

  • Ability to lead a team, inspire community and deliver objectives
  • Capable of grasping/understanding and effectively communicating both scientific and business-related ideas/concepts
  • Possession of advanced knowledge and skill with MS project and other software typically used for project planning, tracking, and reporting    
  • Knowledgeable of facility renovation projects, processes and management in a regulated environment, bridging stakeholders across different companies and functions, as well as managing global communications.
  • Excellent interpersonal skills, organizational abilities, written and verbal communication skills
  • Ability to effectively work in collaborative environment with internal teams, consultants, and other external partners/companies

Remuneration & Benefits

The salary for the Senior/Programme 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. The salaries at Instil Bio UK are offered together with an attractive bonus and benefits package.

Application Process

If you would like to join us as a Senior/Programme 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. 

If you would like to find out more about Instil Bio UK and our roadmap – there is plenty of opportunity for an informal fact-finding chat once you make your application.