Senior Manager, Cell Therapy Manufacturing

Responsibilities

• Serves as manufacturing functional area owner and manages commercial and clinical manufacturing teams and areas.
• Hiring, mentoring and developing exceptional people.
• Conducting performance reviews and identifying opportunities for career growth for supervisors and associates.
• Championing a culture of exceptional teamwork and communication across the organization.
• Ensuring people have and maintain the appropriate level of training necessary for CAR-T GMP manufacturing in a multi-product commercial facility.
• Building effective cross-functional relationships with Quality, Supply Chain, MS&T, EHS and F&E.
• Ensuring a culture that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
• Plans for and executes commercial and clinical operations for a licensed CAR-T product in the Devens CTF Manufacturing Plant.
• Establishing department goals, tracking and reporting KPIs, and driving a culture continuous improvement through innovation and implementing lean manufacturing initiatives.
• Authoring, reviewing and approving documents, including standard operating procedures, batch records, material specifications, training materials and validation protocols / reports.
• Developing and communicating project goals, strategy and timeline with manufacturing management.
• Implementing and operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Ensuring schedules of the people, facility, equipment, materials, and documents are established and maintained to support the expected capacity of the facility for multiple CAR-T products.
• Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
• Championing inspection readiness efforts and initiatives for Right First-Time manufacturing.
• Establishing team policies, organizational structure, shift structure, and career ladders for Associates, Team Leaders, Supervisors and Managers.

Minimum Requirements

• Bachelor's degree in relevant science or engineering discipline, or equivalent in work experience.
• Knowledge of Lean Manufacturing principles required.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Ability to work in the vicinity of strong magnets.
• 8+ years of relevant work experience within pharmaceutical or a similarly regulated industry.
• 6+ years supervising staff in a management role.