Position Summary:
OmniaBio is seeking a Site Head & CTO, Manufacturing Operations to lead, from a manufacturing operations perspective, the transformation of its state-of-the-art facility, completed in 2024. This leadership position will oversee key site functions to ensure the achievement of business goals, uphold quality and compliance standards, and fulfill client needs to supply safe, effective products to patients.
The ideal candidate will foster a culture of continuous improvement, safety, and energy, while maintaining high levels of customer satisfaction. This role demands a high level of leadership, strategic vision, and business acumen. The Site Head will play a critical role in shaping the organizational culture to deliver outstanding results across multiple advanced therapy platforms, while managing profit and loss to meet financial targets.
A key aspect of this role is the critical integration of cutting-edge AI, automation, and robotics manufacturing technologies, including both software systems and task-performing robotic systems. The Site Head will be responsible for driving the deployment and advancement of these digital and robotic systems, ensuring seamless operational integration, enhanced efficiency, and consistent quality in manufacturing processes.
Success in this role requires operational excellence across all site functions to meet strategic and operational objectives, alongside legal and administrative leadership responsibilities. The position requires a balanced approach to aligning client expectations with business needs.
The Site Head will have direct and matrix management responsibility for Manufacturing, Operations, Quality Control, Quality Assurance, Engineering, Facilities, EHS, Continuous Improvement, Compliance, Regulatory Affairs, Project Management Office (PMO), and Supply Chain activities. Reporting directly to the CEO, the successful candidate will collaborate closely with OmniaBio leadership and key stakeholders at the Centre for Commercialization of Regenerative Medicine (CCRM).
Key Responsibilities: Site Head
Lead and oversee all operational activities across the entire batch production value chain, ensuring efficient, compliant, and high-quality manufacturing of Cell and Gene Therapy products.
Ensure that the facility, systems, and workforce are appropriately equipped, trained, and maintained to safely meet the demands of advanced biomanufacturing while adhering to the highest standards of safety, quality, and compliance.
Collaborate with functional department leads to ensure full compliance with all applicable corporate, regulatory, and industry standards, including GMP, ISO, and other relevant guidelines.
Drive site operations to achieve and exceed the company's annual business goals, scaling capacity and capabilities in alignment with growth strategies.
Ensure an exceptional customer experience by delivering on commitments, maintaining open communication through site visits, meetings, teleconferences, and timely, transparent correspondence.
Take ownership of the site’s P&L, as applicable, including budget management, cost control, and financial performance to meet or surpass set targets.
Build, develop, and retain high-performing teams by fostering a positive employee relations environment, including recruiting top talent, setting performance standards, supporting career development, and implementing reward and recognition programs.
Promote a culture of high performance, accountability, and engagement across all levels of the organization.
Develop, monitor, and report on key operational performance metrics and KPIs that inform decision-making, identify areas for improvement, and track progress toward operational excellence.
Cultivate a culture of continuous improvement by implementing lean practices, fostering innovation, and driving process optimizations to maximize efficiency, quality, and throughput.
Ensure EH&S (Environmental, Health & Safety) performance is aligned with, or exceeds, industry best practices, maintaining top quartile rankings across relevant safety and environmental metrics.
Lead digital transformation initiatives by integrating AI, automation, and robotics technologies into manufacturing processes, ensuring seamless operational integration, scalability, and compliance, thereby positioning the site as a leader in automated CGT production.
Act as a strategic leader and influencer, representing the site within the organization, at industry forums, and with external partners, including regulatory authorities and the community.
Key Responsibilities: CTO, Manufacturing Operations
Provide strategic leadership in engineering and manufacturing technology, driving innovation and integration of AI, robotics, automation, and digital systems to optimize production processes across the facility.
Lead the deployment of advanced automation solutions, including physical robots and intelligent software systems, to enhance operational efficiency, throughput, and scalability of Cell and Gene Therapy manufacturing operations.
Develop and implement a comprehensive digital manufacturing ecosystem, emphasizing real-time data collection, analysis, and visualization to monitor process performance, identify bottlenecks, and enable predictive maintenance.
Champion the integration of electronic batch records, manufacturing execution systems (MES), and other digital tools to ensure seamless, paperless, and fully compliant batch documentation and traceability.
Oversee the design and implementation of remote monitoring systems that provide continuous real-time insights into manufacturing equipment, environmental conditions, and product status, enabling swift intervention and reducing downtime.
Drive initiatives aimed at high throughput production with rapid quality release, emphasizing process automation, efficient workflows, and robust quality controls.
Collaborate closely with the Chief Strategy Officer, and the CTOs for Artificial Intelligence and Information Technology, to align manufacturing technology strategies with organizational goals, digital transformation initiatives, and IT infrastructure.
Work jointly with the CTO, Artificial Intelligence, to leverage AI-driven analytics, machine learning, and predictive modeling to improve process performance, quality, and decision-making.
Partner with the CTO, Information Technology, to ensure the security, integration, and scalability of digital manufacturing systems within the broader enterprise IT landscape.
Collaborate with Quality, Regulatory, and Supply Chain teams to ensure that digital and automation systems support compliance, data integrity, and validation requirements.
Lead capacity planning and process optimization efforts, leveraging data-driven insights to maximizing throughput and operational flexibility.
Develop and maintain metrics and KPIs related to automation, digital performance, and manufacturing efficiency, utilizing these insights for continuous improvement.
Foster a culture of innovation, experimentation, and continuous learning within the engineering and manufacturing teams, promoting adoption of cutting-edge technologies.
Ensure that the manufacturing infrastructure, systems, and automation strategies align with industry best practices and future technological advancements, securing competitive advantage.
Act as a technical authority and internal expert on smart manufacturing systems, offering guidance on system integration, cybersecurity, and data governance.
Leadership Qualifications:
Motivate, inspire, build and retain highly effective teams
Versatile learning and courageous decision making
Candid, direct, and comfortable with complexity and ambiguity
Effective operating in an evolving, complex, and dynamic environment, providing clear direction and instruction to direct reports, and continuously searching internally and externally for best practices and areas of improvement.
Effective communicator/influencer with senior leadership and clients
Set ambitious and realistic targets, drive for results, and build accountability within the organization
Understand and study the evolving Cell and Gene Therapy/Advanced Therapy Technologies within this rapidly growing field.
Drive to continuously improve operations by setting high standards. Embrace change, innovation and initiate new and improved ways of operating.
Colloaborate effectively with peers, stakeholders and partners across OmniaBio and CCRM to positively impact business results.
Qualifications:
Educational Background:
Bachelor's degree in Engineering, Biotechnology, or a related technical field is required.
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, Bioengineering, Systems Engineering, or Business Administration with a focus on operations or technology preferred.
Professional Experience:
Minimum of 15 years of progressive senior leadership experience in biopharmaceutical manufacturing, with a strong emphasis on cell and gene therapy or advanced biologics production.
Proven track record of leading large-scale manufacturing facilities, including full P&L responsibility.
Extensive experience in integrating advanced manufacturing technologies such as AI, automation, robotics, and digital systems into GMP operations.
Demonstrated expertise in implementing digital transformation initiatives, including electronic batch records, MES, remote monitoring, and real-time data analytics.
Strong background in engineering management, process optimization, and continuous improvement methodologies (e.g., Lean, Six Sigma).
Experience managing multi-disciplinary teams across manufacturing, quality, engineering, facilities, supply chain, and regulatory functions.
Familiarity with regulatory compliance in regulated environments (FDA, EMA, Health Canada, etc.).
Experience with capacity planning, scale-up, and commercial manufacturing of complex biologics and cell/gene therapies.
Leadership & Strategic Skills:
Proven ability to lead transformational change and foster innovation within a high-growth, regulated environment.
Strong business acumen with experience managing budgets, P&L, and strategic planning.
Exceptional communication, collaboration, and stakeholder management skills, with the ability to engage with executive leadership, partners, and external regulators.
Technical & Digital Skills:
Deep understanding of manufacturing automation, robotics, AI, data analytics, and cybersecurity related to biomanufacturing.
Experience with digital systems such as MES, ERP, remote monitoring, and electronic batch recording.
Knowledge of Industry 4.0 principles and best practices in smart manufacturing.
Other Qualifications:
Strong problem-solving and decision-making skills.
Ability to operate effectively in a fast-paced, matrixed organizational structure.
Commitment to maintaining top safety, quality, and compliance standards.
