Manufacturing Manager Clinical Cell Therapy

Position Overview:

The company's Genomic Medicine Unit (GMU) CMC group is dedicated to the establishment of best-in-class manufacturing platforms to support the development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, and lentiviral vectors, and cell therapy products. The company is looking for a cell therapy leader with GMP manufacturing expertise to serve as Manager of Clinical Cell Therapy Manufacturing. This is an exciting opportunity to join the company's GMU and be part of building the company's cell therapy manufacturing strategy. The ideal candidate will have expertise in cell therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions. Creativity, scientific thoroughness, entrepreneurial mindset, and the ability to function in a complex environment are essential.

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, by providing hands-on technical leadership and operational oversight for a cell therapy manufacturing suite in Framingham, MA. 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 product 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, engineering or related discipline with a minimum of 8 years of industry experience or a Master's degree with a minimum of 6 years of industry experience.
• A minimum of 2 years managing direct reports or project teams.
• 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:

• Cell Therapy experience
• 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.

Recommended Skills

• Business Planning
• Change Management
• Clinical Works
• Communication
• Creativity
• Engineering