Digital Site Head

RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent – investing in innovation every step of the way.

We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.

RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.

We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.

The Digital Sites Head will lead digital operations across our Toronto area sites (offices, manufacturing facilities, process & analytical development labs, warehouses) and will be responsible for the team that deploys, operates, maintains, and supports IT infrastructure, applications, service delivery and executes on continuous improvement initiatives. While reporting into the Resilience Digital team at the network/central level, you will also serve on the senior leadership team of the sites in a matrixed capacity with a dotted line to the General Manager.

• Responsible for the team that deploys, operates, maintains, and supports IT infrastructure, applications, service delivery and executes on continuous improvement initiatives. While reporting into the Resilience Digital team at the network/central level, the Site lead will also serve on the senior leadership team of the sites in a matrixed capacity with a dotted line to the General Manager.

• Lead complex, strategic and mission-critical initiatives from inception through delivery with broad business and technology influence and impact. These include major capital projects, cloud migration, qualification and validation of GxP systems, and adoption of the Resilience Digital Platform that brings never-before-seen digital capabilities to the industry.

• Build and manage a local team that covers network engineering, systems engineering, end-user support and ongoing management and upgrades of laboratory, quality and manufacturing systems for which you will serve as the technical system owner. Be the primary link back to the Digital org with the voice of the “customer”, and you will be accelerating the maturation of the site’s capabilities by drive sitewide adoption of the Resilience Digital Platform.

• Assess risk, drive clarity, and foster shared understanding. You will create the correct sense of urgency for delivery, map clear process flows and identifies opportunities on how to eliminate points of failure, inefficiency, and waste, and coach others on how to do it. Deliver solutions that meet high standards for quality, efficiency, stability, extensibility, simplicity, and operational excellence. Create, optimize, and drive adoption of the critical mechanisms that ensure that projects will be successful in the long-term with or without your continued involvement.

The preferred candidate has a history of leading successful continuous improvement initiatives, managing Agile digital operations, familiarity with DevOps practices and deployment methodologies in the on-prem, cloud, and hybrid environments, and working cross-functionally in a biomanufacturing operation. You see opportunities in challenges, you find paths forward where others have not ventured, and you consistently ask “what’s a better way” to automate the modern biomanufacturing operation.

Responsibilities

• Provide Digital site leadership enabling business operations, digital infrastructure, and digital applications for multi-modal manufacturing operations.

• Improve site-based operations and procedures in alignment with Resilience digital strategy

• Deploy and run Resilience Digital infrastructure and applications that integrate with the Resilience Digital Platform along with the digital plant maturity model.

• Partner and collaborate with site leadership to implement the Digital strategy across end-user operations & helpdesk, manufacturing, labs, quality, and the total Digital integration of the systems within the plant.

• Champion Industry/Pharma 4.0 maturity

• Champion IIoT and modern approaches

• Champion use of the hyperscale public cloud in operations & automation

• Establish policy and procedure across site stakeholders and digital domains

• Develop joint success metrics shared between digital and our site stakeholder groups tracking and reporting this data as the foundation for measurable digital performance

• Lead a diverse team of systems engineers, and key supporting contractors and vendors

• Lead the implementation of the Digital infrastructure capability of our Resilience Digital Platform (RDP) at the site as the platform evolves and shapes how we operate

• Manage Digital site project budgets, digital architecture, project engineering, project management, and own delivery of processes and technical resource management

• Ensure the digital resilience of our site operations by maintaining our governance standards with special attention to compliance programs for our IT support and supply chain (vendors, ISVs, others who access physical systems in our plants), aligned with proper IT change management approaches that integrate with our GxP and Quality processes.

Requirements

• In-depth knowledge of manufacturing technologies and systems at all levels of the ISA95 stack relevant to process automation and manufacturing (e.g. PLCs, PCS/DCS, SCADA, MES, ERP)

• Deep experience with the requirements and constraints of regulated environments including 21 CFR 11, cGMP, and GAMP.

• Hands-on experience managing IT infrastructure such as compute, storage, database, network (e.g. VMWare, AWS).

• Operational experience with IT change management across domains (security, software, network, hardware, etc)

• Prior experience in managing digital teams in high-velocity and regulated environments.

• Experience with hyperscale public cloud (preferably AWS) and key approaches to security and change management/deployment (e.g. Infrastructure-as-Code)

• Accountability/Responsibility of 24/7/365 mission-critical services and IT teams in Manufacturing, Laboratory, and Quality realms.

• Fluid collaboration skills across business, IT, and external vendors/suppliers

• Bachelor’s degree or higher

• Proven track record of improving the end-to-end value chain and experience in a manufacturing environment

• Strong track record of operating creatively and autonomously in both startup and enterprise environments

• Strong hands-on project and operations management

• Exceptional analytical and quantitative skills; Experience using data and metrics to test theories, confirm assumptions, and measure success

• Exceptional verbal and written communications skills

• Apply rigorous approach to problem-solving

• Demonstrated ability to handle multiple competing priorities and projects in a fast-paced environment with a proven track record for delivering results on large, cross-functional, global projects

• Proven ability to execute as an individual contributor, leader, and leader-of-leaders, in the face of ambiguity, shifting priorities, and limited resources

ADDITIONAL REQUIREMENTS:

• 15+ years of experience in manufacturing operational technology (OT) and information technology (IT) environments, implementing and supporting Part 11 compliant systems and processes in biopharma.

• Fluency in supporting the digitization of Biopharmaceutical technical operations by bringing the IT know-how to business partners in manufacturing, laboratory or quality

• Builder mentality that seeks to produce innovation, agility, and velocity to support business-as-usual operations and new project implementation.

• Lean or six sigma experience including process mapping and process re-design

This job profile provides an overview of the minimum requirements of the job and does not include all the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.

While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team.

NOTE: All employment is conditional upon completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

Benefits:

• Dental care
• Employee assistance program
• Extended health care
• RRSP match
• Wellness program

Schedule:

• Monday to Friday

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