Supervisor, Manufacturing

Manufacturing Supervisor For Cell Therapy OperationsWe 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.ResponsibilitiesLead, 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 requirementsProvide 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 mannerLead and oversee manufacturing processes including engineering runs, PPQ and APSEnsure 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 standardsResponsible for and has the authority to make spot corrections and provide feedback on process and procedure adherence to employees in the cleanroomOperate in a controlled GMP environment and perform gowning as per procedurePerform 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 troubleshootingReview 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 completionInitiate, investigate, and support the closure of Deviation Reports, CAPAs and Change ControlsResponsible for revising and originating production records, standard operating procedures, protocols and reportsAccountable for schedule preparation, adjustments and performance of work assignments for teamCoordinate and perform routine cleanroom and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenanceOversee the hiring, development, and performance management of staff within teamFollow 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 sameTrain and mentor new manufacturing associates on procedures, aseptic techniques, equipment and trouble-shooting skillsResponsible for team's training status to be compliantActively participate in all health authority, customer, and internal audits of the facilityWork closely with other functional areas to execute against the strategic plan for the manufacturing siteMonitor, and improve production metrics related to Safety, Quality, Compliance, Cost, Delivery, and People Identifies process and method gaps and opportunities and implements improvementsIdentifies, participates, suggests solutions and options and leads complex technical problem solving, cGMP compliance and regulatory gap closure and continuous improvement ideasParticipates 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 transferProvide feedback to engineering and process teams, support with requirements gathering and reviewAssist in the execution of process and equipment qualification and validationEstablish key stakeholder relationships with internal stakeholders and clientsWork with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignmentsOther duties as assignedRequirementsBachelor's degree in science, engineering, or related field requiredA 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 managementPrevious experience interacting directly with the FDA and other regulatory agencies. Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standardsDemonstrated experience in managing GMP manufacturing operations and on time delivery of quality productsMust be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team membersDevelop 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 planningAbility to execute and deliver resultsStrong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountabilityExcellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels within the organizationDesire to be part of a rapidly evolving organization, with compelling technology, and take products and processes to the next levelExperience with Operational Excellence and/or Lean Manufacturing. Lean Six Sigma certification preferredExcellent organizational and communication skillsSelf-awareness integrity, authenticity, and a growth mindset$90,000 - $210,000 a year Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.