Supervisor, Manufacturing

Responsibilities

• Lead, direct, coach, and develop an effective manufacturing team responsible for daily clinical and commercial/clinical 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
• Lead and oversee manufacturing processes including engineering runs, PPQ and APS
• Ensure manufacturing processes in both an R&D and GMP environments are following appropriate protocols and/or standard operating procedures (SOPs)
• Responsible for on the floor operation performance, overall performance of aseptic technique and process execution, ensuring compliance with standards
• Responsible for and has the authority to make spot corrections and provide feedback on process and procedure adherence to employees in the cleanroom
• Operate in a controlled GMP environment and perform gowning as per procedure
• Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
• Execute manufacturing processes in both an R&D and GMP environments, following protocols and/or standard operating procedures (SOPs)Understands all operations, functions, capability of equipment and ancillary support to equipment, is able to operate said equipment and is able to perform complex troubleshooting
• Review in-process and completed documents for accuracy including SAP issuance of materials and assure documentation is turned in to area management within specified days of completion
• Initiate, investigate, and support the closure of Deviation Reports, CAPAs and Change Controls
• Responsible for revising and originating production records, standard operating procedures, protocols and reports
• Accountable for schedule preparation, adjustments and  performance of work assignments for team 
• Coordinate and perform routine cleanroom and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenance
• Oversee the hiring, development, and performance management of staff within team
• Follow compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understand ‘why’ behind the regulations.  Able to coach and mentor others to do the same
• Train and mentor new manufacturing associates on procedures, aseptic techniques, equipment and trouble-shooting skills
• Responsible for team’s training status to be compliant
• Actively participate in all health authority, customer, and internal audits of the facility
• Work closely with other functional areas to execute against the strategic plan for the manufacturing site
• Monitor, and improve production metrics related to Safety, Quality, Compliance, Cost, Delivery, and People Identifies process and method gaps and opportunities and implements improvements
• Identifies, participates, suggests solutions and options and leads complex technical problem solving, cGMP compliance and regulatory gap closure and continuous improvement ideas
• Participates on and performs technical transfer activities e.g. provides feedback for facility fit, is able to recommend and identify improvements as the process develops during phases of technical transfer
• Provide feedback to engineering and process teams, support with requirements gathering and review
• Assist in the execution of process and equipment qualification and validation
• Establish key stakeholder relationships with internal stakeholders and clients
• 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 6+ 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. With experience in tech transfer, process validation, 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 and on time delivery of quality products
• 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 
• Ability to execute and deliver results
• 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