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.
Technical Trainer, Technical Services
Instil Bio is seeking a driven and experienced Technical Trainer, in Manufacturing Technical Services department. The successful candidate will initially perform startup activities in support of Clinical manufacturing readiness and launch. Some of the responsibilities include, establishing a robust training and qualification program for manufacturing operators, creating manufacturing documents – SOPs, batch records, etc., and managing equipment annual re-qualification activities.
The candidate must be experienced in Cell Therapy. This role will comprise of multiple critical functions:
- Support the Associate Director, Technical Services in creating a Training Program and curriculum for Manufacturing operators that adheres to regulatory requirements.
- Create Training program for on-boarding manufacturing operators and support on-going training
- Setting, communicating, tracking, and reporting KPI’s for the training qualification program
- Lead a continuous improvement culture; work cross-functionally with Manufacturing, Manufacturing Sciences and Technology (MSAT) and Quality to implement changes associated with training
- Develop cross functional mentoring program to improve skill set and development opportunities
The role is not required to be on a shift pattern. 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:
- Ensure staff is compliant and training is complete on time
- Training program continuous improvements
- Right First-Time lead
- Participates in audits and inspections by presenting training program and qualification as applicable
- Develops and provides hands-on training / guidance on MFG compliance, and reinforces cGMPs to increase quality and compliance knowledge throughout MFG organization
Requirements and Recommendations:
- BA degree in Life Sciences, Engineering, Applied Physics, or a related field with 3+ years of manufacturing or related experience
- Solid experience with cGMP’s in a manufacturing facility, including Cell Therapy experience.
- Excellent communication and writing skills.
- Strong desire for experience in startup/qualification of facility and process
- Adapting and thriving in a rapidly changing and fast-moving environment.
- 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.