Sr Manager/Manager, U.S. Clinical Manufacturing

ABOUT InstilBio 

InstilBio Inc, a cell therapy company focused on solid tumors, has recently acquired Immetacyte Ltd. InstilBio is developing patient specific immunotherapies in oncology, allowing the patient’s own immune system to be harnessed to fight cancer. The world-renowned team and its scientific advisors/investors have tremendous experience and track record in technology discovery, process development, GMP manufacturing and clinical operations with a track record of developing and gaining approval for successful cell therapies.

We have built upon the expertise of researchers who have successfully undertaken scientific and clinical research alongside Professor Robert Hawkins. Professor Hawkins is a leader in the field having undertaken several complex research projects and clinical trials involving: TIL, CAR-T, TCR based T cell therapies, cell selection, gene therapy, expansion of patient derived cells.

Recent significant investments in InstilBio are enabling the company to undertake Phase 2/3 to registrational clinical trials in melanoma.  Further trials are planned in other solid tumor indications and using gene-modified approaches to build a pipeline of TIL-based therapies.

Senior Manager/Manager, U.S. Clinical Manufacturing

Instil Bio is seeking a driven and experienced Sr Manager/Manager, U.S. Clinical Manufacturing.  The successful candidate will initially perform startup activities in support of Clinical manufacturing readiness and launch. Some of the responsibilities include, operational readiness, ensuring personnel are qualified for manufacturing operations, and hiring talent to build his/her team.

The candidate must be experienced in Cell Therapy. This role will comprise of multiple critical functions:

  • Support the Director of Manufacturing in strategic planning and leadership to meet site and global goals and KPIs
  • Hire and develop team of technical team members to execute clinical manufacturing and associated activities
  • Ensure manufacturing operations adhere to regulatory requirements (US, UK, EU)
  • On-boarding and training of manufacturing operators, and ensuring their training is up to date.
  • Through implementation of Continuous Improvement philosophy, manage and improve pharmaceutical standards, awareness & compliance within the technical team (measures: CAPA close out, non-conformance/deviation close out, clean room standards, engineering standards).
  • Implement operational excellence principles to ensure accelerating manufacturing cadence meets clinical targets
  • Setting, communicating, tracking, and reporting Key Performance Indicators (KPI’s) at a personal and departmental level
  • Champion a continuous improvement culture; work cross-functionally with Manufacturing Sciences and Technology (MSAT) and Quality to improve manufacturing operations in a compliant manner
  • Established Service Level Agreement between Tech Services and Quality
  • Develop cross functional mentoring program to improve skill set and development opportunities
  • Create KPIs and goals for the team

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.

Responsibilities (include but not limited to):

  • Responsible for maintaining inspection readiness within Manufacturing in the following ways:
    • Identify, propose, and executes compliance process and procedural changes to reduce deviations.
    • Implements corrective actions.
    • Leads Manufacturing Production area walk through for housekeeping as applicable to driver 5S and manufacturing lean initiatives.
    • Participates in audits and inspections by presenting deviations and change controls to the auditors/inspectors with support.
  • On-site clinical Production
  • Develops and provides hands-on training / guidance on MFG compliance, and reinforces cGMPs to increase quality and compliance knowledge throughout MFG organization
  • Independently initiates lean manufacturing operation techniques in order to actively reduce cycle times. Identifies moderate to complex projects for operational improvements and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains (lean manufacturing, 5S, operational improvements)

Requirements and Recommendations:

  • BS degree in Life Sciences, Engineering, Applied Physics, or a related field with 5+ years of manufacturing or related experience
  • 3+ years of managing people and teams
  • Solid experience with cGMP’s in a manufacturing facility, including Cell Therapy experience.
  • Strong desire for experience in startup/qualification of facility and process
  • Excellent communications and writing skills with direct experience supporting significant strategy development & implementation.
  • Adapting and thriving in a rapidly changing and fast-moving environment.
  • Direct experience in a cross-functional business operation or strategic project management role or continuous improvements.
  • Demonstrated leadership capabilities to engage and motivate, including the ability to mentor and develop highly educated and energized employees to become future leaders and key contributors to Instil Bio’s organization.