Manager, Cell Therapy Manufacturing

Position Summary
We are seeking an innovative and highly motivated Manager for Manufacturing to join our team who will be responsible for ramp-up and oversight of the cGMP operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products. This individual will partner with other functions to produce cell therapy products through safe and compliant manufacturing operations according to cGMP requirements. As such, the role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups to ensure robust production, testing, and release of product to patients.
This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Commercial, Quality, MSAT, QC, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, EH&S, and Finance.
The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

• Lead, direct, coach, and develop an effective manufacturing team responsible for daily clinical and production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirements 
• Provide technical and managerial leadership by effectively interfacing and collaborating with key stakeholders and functions across the organization to successfully manufacture and disposition products to patients in a timely manner
• Monitor, and improve production metrics related to Safety, Quality, Compliance, Cost, Delivery, and People 
• Oversee the hiring, development, and performance management of staff within manufacturing 
• Lead and actively participate in all health authority, customer, and internal audits of the facility
• Serve as the Manufacturing Host for audits by leading tours and serving as SME for the facility 
• Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site
• Establish key stakeholder relationships with internal and external stakeholders
• Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion
• Responsible for revising and originating production records, standard operating procedures, protocols and reports
• Initiate, investigate, and support the closure of Deviation Reports and CAPAs
• Ensure manufacturing processes in both an R&D and GMP environments are following appropriate protocols and/or standard operating procedures (SOPs)
• Provide feedback to engineering and process teams, support with requirements gathering and review
• Contribute to analysis and presentation of technical results at departmental meetings and with clients
• Perform routine clean room and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenance
• Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments
• Other duties as assigned

Requirements

• Bachelor's degree in science, engineering, or related field required 
• A minimum of 8+ years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 3 years leadership experience. Cell/Gene Therapy experience required, CDMO experience preferred 
• Experience in tech transfer, process validation, project management, and change management 
• Previous experience interacting directly with the FDA and other regulatory agencies. Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards
• Demonstrated experience in managing GMP manufacturing operations 
• Demonstrated startup experience or leading organizations through dramatic growth 
• Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment 
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
• Develop and build cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning 
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability 
• Excel