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