Supervisor, Manufacturing

Position Summary

We are seeking an innovative and highly motivated Manufacturing Supervisor for Cell Therapy Operations 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 Manufacturing, Quality, MSAT, QC, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities and EH&S.

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 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