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.
Instil Bio is seeking a driven and experienced Associate Director of Manufacturing Technical Services.
The successful candidate will initially perform startup activities in support of Clinical manufacturing readiness and launch. Some of the responsibilities include, operational readiness, establishing a
training program for manufacturing operators, creating manufacturing documents – SOPs, batch records, etc., managing equipment qualification, hiring talent to build his/her team.
The candidate must be experienced in Cell Therapy. This role will comprise of multiple critical functions:
• Support start-up activities and operational readiness
• Hire and develop team of process engineers and technical writers
• Create Training program for on-boarding manufacturing operators and support on-going training
• Create Manufacturing documents and support on-going revisions – SOPs and Batch Records
• Work closely with Validation team to manage Equipment IOQs – initial state
• Manage projects, deviation investigations, CAPAs and Change Controls as well as provide guidance on complex manufacturing related matters
• In depth knowledge of cGMP systems and regulations
• Partner with MSAT for successful execution of tech transfers and process improvements
• Established Service Level Agreement between MFG and Quality
• Develop cross functional mentoring program to improve skill set and development opportunities
• Create key performance indicators (KPIs) and goals for the team
The candidate is responsible for managing the training program, investigations & CAPAs, own change control records, and lead projects in support of Manufacturing Operations. The candidate
will represent deviations, CAPAs and change controls during regulatory audits and efficiency gains.
Responsibilities (include but not limited to):
• Responsible for maintaining inspection readiness within Manufacturing in the following
o Identify, propose, and executes compliance process and procedural changes to reduce deviations.
o Implements corrective actions.
o Leads area walk through for housekeeping as applicable
o Participates in audits and inspections by presenting deviations and change controls to the auditors/inspectors with support.
• Develops and provides hands-on training / guidance on MFG compliance, and reinforces cGMPs to increase quality and compliance knowledge throughout MFG organization
• Initiates lean manufacturing techniques to actively reduce cycle times. Identifies moderate to complex projects for operational excellence tools to reduce process variability and
steadily deliver measurable efficiency gains.
• Coach and mentor Manufacturing Tech Services staff and support staff by providing guidance in decision making, determining strategy, authoring change controls. Provides support and guidance to other project team members.
Requirements and Recommendations:
• BS degree in Life Sciences, Engineering, Applied Physics, or a related field with 5+ years of manufacturing or related experience
• Solid experience with cGMP’s in a manufacturing facility, including Cell Therapy experience.
• 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.