About this job
Marker Therapeutics is seeking a Supervisor for its Manufacturing group to support its ongoing efforts to develop immunotherapies for the benefit of patients with cancer. The Manufacturing Supervisor is responsible for the development and implementation of the manufacturing processes used to manufacture Marker’s cell therapy products. He/she will define and direct the activity with internal and external organizations (e.g. contract manufacturing organizations, CMO) to plan, execute, and document early manufacturing that define the product and process of Marker’s cell therapies. The successful candidate must be a team player with strong expertise in cell therapy manufacturing and must have the ability to communicate and collaborate within an interdisciplinary environment.
- Be the primary point of contact with CMOs, manage day-to-day operations and provide technical support of GMP manufacturing runs for ongoing clinical studies carried out by CMOs
- Work closely with QA and CMOs as applicable for successful resolution of deviations, CAPAs, Change Controls, etc.
- Manage timelines and deliverables for technology transfer to CMOs including raw material and equipment procurement
- Conduct onsite or offsite training of contract manufacturing personnel on manufacturing processes
- Work closely with internal stakeholders to map out and execute process improvement activities to drive alignment, simplification and cost reduction
- Participate in internal technology transfer activities, planning meetings and interact effectively with cross functional departments
Minimal Experience and Skills
- BS/MS with 5 – 7 years of experience in pre-clinical development, or cGMP manufacturing of clinical and/or commercial programs, with experience in cellular therapies a significant plus
- Experience working with CMOs, and experience conducting tech transfers highly desirable
- Good understanding of applicable regulations and standards (e.g., GMP, and AABB)
- Prior cGMP manufacturing experience for clinical-stage cell or gene therapies is highly favorable
- Attention to detail, ability to problem-solve, manage workflow, meet deadlines, communicate and work in a fast-paced team environment required.