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.
