Associate Director, GMP Facilities

BlueRock Therapeutics; Toronto; On-site; CAD 120,000 - 160,000; Full time

Job summary

A clinical-stage biotechnology company in Toronto is seeking an Associate Director for GMP Facilities. This role is pivotal in ensuring the smooth operation of manufacturing technologies while maintaining compliance. Applicants should have extensive experience in biopharma settings and be adept in managing technical issues, team leadership, and regulatory requirements. A strong commitment to quality and safety is essential. The company offers a dynamic culture with a focus on innovation and collaboration.

Benefits

Best Places to Work (Mid-size Company) 2023

Best Company for Diversity 2022

Best Company for Women 2022

Qualifications

• 13+ years of experience with 11+ years in a biopharma setting.
• Experience with regulatory and cGMP requirements for aseptic manufacturing.
• Ability to prioritize diverse activities while meeting commitments.

Responsibilities

• Manage asset life cycles for GMP manufacturing equipment.
• Provide technical expertise for troubleshooting production unit processes.
• Develop, review, and implement recommendations to improve reliability.

Skills

Troubleshooting complex equipment

Interpersonal communication

Planning and organization

Regulatory knowledge

EHS risk management

Education

Bachelor’s degree in life sciences

Tools

CMMS

Excel

SAP

Job description

Overview

BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

Associate Director, GMP Facilities – Toronto

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 both technical (i.e. equipment breakdowns) and non-technical topics (i.e. facility cleaning service contracts), the scheduling and execution of maintenance activities including plant shutdowns, the planning/execution of both 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 individual will be accountable for maintaining GMP compliance of the systems and executing remediation as required. The individual is also accountable for routine system data reviews, alarm response & notifications and stakeholder management of impacted users.

The position is an anchor/on-site position that leads a team of anchor/on-site employees and will also provide leadership to License to Operate (LTO) topics within the facility (Safety and Quality).

The Associate Director will provide effective leadership including: individual goal setting/performance reviews, managing the development of employees and team members, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area.

The position reports to the VP Engineering & MSAT and is a member of the Engineering & MSAT leadership team.

The Associate Director, GMP Facilities, must excel in fast-paced environment, be able to execute on functional builds relevant to GMP Facilities while maintaining agility for an early phase biotech. This leader will engage with all levels within the organization and regularly provides direction and strategy.

Key Responsibilities

• Manage asset life cycles for GMP manufacturing equipment, utilities, facility and HVAC.
• Provide the necessary 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 resolution of 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 the 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.
• 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 workflow for non-routine work and for contractor management strategies to identify and mitigate hazards.
• Other duties as assigned.

Qualifications

• Bachelor’s degree or higher in life sciences field with 13+ years of experience including 11+ years in a biopharma setting, or no degree and 14+ years of experience.
• 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 knowhow.
• Experience building budgets and maintaining control of area of fiscal responsibility.
• Demonstrated understanding of EHS risk management and demonstrated experience integrating EHS principles into facilities management.
• Demonstrated ability to troubleshoot complex equipment / 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 skills to effectively communicate with a diverse wide customer base.
• Strong planning and organizational skills.
• Good oral and written communication skills.
• High level of urgency and is able to quickly adapt to changing priorities.
• Flexibility to support business requirement of rotational on-call support and / or weekend coverage.
• Experience with FAT, SAT, Commissioning and Qualification, including hands on experience starting-up and running new equipment, resolving technical equipment issues, developing turn-over packages.
• Experience with Process Control Systems, including DCS, PLC, instrumentation and low voltage electrical systems.
• Proficient computer skills to include Excel, Word and PowerPoint, SAP experience helpful.

#LI-AL1

BlueRock Therapeutics Company Culture Highlights

Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023

Winner of Comparably's Award for Best Company for Diversity 2022

Winner of Comparably's Award for Best Company for Women 2022

Winner of Comparably's Award for Best CEO 2022

BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.

Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.

Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics

Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/

Equal Opportunity Workplace

Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.