Salary Range: 90000 to 210000 (Currency: USD) (Pay period: per-year-salary)

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 
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organization 
• Desire to be part of a rapidly evolving organization, with compelling technology, and take products and processes to the next level
• Experience with Operational Excellence and/or Lean Manufacturing. Lean Six Sigma certification preferred
• Excellent organizational and communication skills 
• Self-awareness integrity, authenticity, and a growth mindset