Associate Director, GMP Facilities

OverviewBlueRock Therapeutics LP is a clinical stage cell therapy company focused on developing therapies for neurological and ophthalmic diseases. We are seeking individuals who are collaborative, thrive in a dynamic culture, and are committed to advancing cutting-edge cellular therapies to impact patients’ lives.Based in Toronto, Ontario, the Associate Director, GMP Facilities provides the technical knowledge and is accountable for troubleshooting, planning, coordinating, and executing technical and non-technical activities needed to support GMP Manufacturing in BlueRock’s Toronto sites. The position is responsible for the timely resolution of technical and non-technical topics, scheduling and executing maintenance activities including plant shutdowns, planning and executing OPEX & CAPEX projects, and supporting technology transfer.The Associate Director will be the technical system owner of BlueRock’s Computerized Maintenance Management System (CMMS), Environmental Monitor Solution and Building Management System. The role includes maintaining GMP compliance of the systems, executing remediation as required, routine system data reviews, alarm response & notifications, and stakeholder management of impacted users.The position is an anchor/on-site role that leads a team of anchor/on-site employees and provides leadership on License to Operate (LTO) topics within the facility (Safety and Quality). It reports to the VP Engineering & MSAT and is a member of the Engineering & MSAT leadership team. The Associate Director, GMP Facilities must excel in a fast-paced environment, execute functional builds relevant to GMP Facilities, and maintain agility for an early phase biotech. This leader will engage with all levels within the organization and regularly provide direction and strategy.Key ResponsibilitiesManage asset lifecycles for GMP manufacturing equipment, utilities, facilities and HVAC.Provide technical expertise for troubleshooting and resolving problems with Production Unit processes and equipment; collect, analyze and report equipment downtime information; ensure resolution of critical equipment items. Perform risk assessments and resolve risk analysis.Understand and maintain the CMMS, EMS & BMS. Develop and monitor alarms as appropriate.Resolve Quality action items and write Engineering Assessments as Subject Matter Expert (SME).Coordinate maintenance activities and shutdown requirements for production equipment and facilities.Develop, review and implement recommendations to improve reliability of infrastructure and production systems. Maintain calibration, maintenance and safety procedures in defined area of responsibility.Direct and supervise the BlueRock facilities team. Manage employees, contractors and consultants as required to maintain safe and operational facilities.Serve as engineering lead in support for audits conducted by internal and external agencies.Support a proactive EHS culture by ensuring timely closure of EHS actions and maintaining alignment with regulatory and internal standards.Partner with EHS to create Job Safety Analysis workflows for non-routine work and for contractor management strategies to identify and mitigate hazards.Other duties as assigned.QualificationsBachelor’s degree or higher in life sciences with 13+ years of experience including 11+ years in a biopharma setting, or 14+ years of experience without a degree.Experience with regulatory and cGMP requirements for aseptic pharmaceutical manufacturing.Experience with qualification engineering.Demonstrated understanding of industry guidelines, regulatory requirements, and relevant SOPs.Experience with CMMS, EMS, BMS systems.21CFR Part 11 know-how.Experience building budgets and maintaining control of the area of fiscal responsibility.Demonstrated understanding of EHS risk management and experience integrating EHS principles into facilities management.Demonstrated ability to troubleshoot complex equipment and systems and supporting utility services.Ability to troubleshoot equipment failures immediately and communicate status to engineers and production.Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.Strong interpersonal, planning and organizational skills with good oral and written communication.High level of urgency and ability to adapt to changing priorities.Flexibility to support rotational on-call and/or weekend coverage.Experience with FAT, SAT, Commissioning and Qualification, including hands-on experience starting up and running new equipment, resolving technical issues, and developing turnover packages.Experience with Process Control Systems (DCS, PLC, instrumentation) and low voltage electrical systems.Proficient computer skills (Excel, Word, PowerPoint); SAP experience is helpful. #J-18808-Ljbffr