Description
Key Responsibilities:
The primary accountability of this role is to enable the manufacturing of cell therapy products for clinical supply, as a cell therapy technical expert for cGMP manufacturing, through providing hands-on technical leadership and operational oversight for our cell therapy manufacturing suite. We are looking for a candidate with excellent GMP, scientific, technical, communication, and leadership skills.
Specifically:
Provide leadership to oversee the operation of a GMP cell therapy manufacturing operations team.
Manage operational staff, including developing staff capabilities through initial and ongoing training and maintaining team compliance.
Provide management oversight of tech transfer activities.
Provide management oversight of drug products production.
Manage the production schedule and the daily tasks of the Manufacturing Operators.
Provide oversight and guidance related to training materials, SOPs, batch records, reports, risk assessments, materials management, etc.
Work cross-functionally with process development, quality, and other counterparts for the development of next-generation cGMP cell therapy manufacturing processes.
Works closely with senior management to initiate new projects and assist in developing processes/techniques to meet business objectives.
Basic Qualifications:
Bachelor's degree in sciences or engineering discipline with a minimum of 7 years of industry experience or a Master's degree with a minimum of 5 years of industry experience.
2 years in managing direct reports or project teams.
2 years of experience in cell therapy.
Experience in GMP documentation and compliance.
Ability to operate and thrive in a fast-paced, high-growth environment.
Strong skills in change management.
Excellent communication skills.
Preferred Qualifications:
PhD in a sciences or engineering discipline.
Direct experience in cell GMP manufacturing facilities with expertise in CAR-T, NK cell therapy.
Involvement in delivering a cell therapy-based product into clinical development.
