Senior Program Manager, Platforms

About CCRM and OmniaBio:

CCRM, based in Toronto, Canada, is a public-private partnership that is developing and commercializing cell and gene therapies and regenerative medicine-based technologies. We are leveraging our network of academics, industry partners and investors to tackle significant industry challenges and advance our most promising technologies to the market to meet the needs of patients. For more information about CCRM, please visit our website at ccrm.ca.

OmniaBio Inc. is a subsidiary of Toronto-based CCRM (ccrm.ca), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is expected to be the largest facility of its kind in Canada.

Department:        Technology Platforms

Position Summary:

As Senior Program Manager, Platforms, at CCRM, you will be part of a diverse cell and gene therapy (CGT) and bioengineering team focused on designing and implementing platform technologies encompassing three focus areas: induced pluripotent stem cells (iPSC), immunotherapy and viral vectors. These platform technologies support research and development (R&D) and/or Good Manufacturing Practices (GMP) within the cell and gene therapy and regenerative medicine fields for CCRM and OmniaBio, a CDMO subsidiary of CCRM. You will apply program and project management, and client and contract management expertise, to ensure that both internal and external projects are planned, run and completed in a timely and efficient manner and on budget. Working with the Chief Development Officer (CDO), platform heads and cross-functional teams, you will be responsible for developing, monitoring, project scoping, budgeting, task planning, and prioritizing to support the execution of programs for the platforms by R&D and/or GMP groups. This will include internal projects, fee-for-service contract manufacturing, and other valuable service offerings to the organization. You will also be responsible for ensuring smooth, effective and efficient communication, project co-ordination, and collaboration between the platform teams, as well as between the platforms and the rest of CCRM and OmniaBio.

Responsibilities:

Client and Vendor Contract Management/Engagement

• Supports, leads, and/or organizes internal and external meetings to manage or establish relationships and contracts for CCRM projects and services, in collaboration with the CDO and platform heads.
• Manages contract and license negotiations with external vendors or technology holders, as needed, in collaboration with the CDO and platform heads.
• Works with the CDO to improve CCRM project, client and contract management tools to enhance interactions with various stakeholders, such as client-facing project managers, and Legal and Finance teams.
• Works with the CDO to build and improve technology development plans across platforms and address gaps, including within planned work packages.
• Maintains regular contact with internal stakeholders to ensure effective and timely communication,  customer satisfaction and delivery of milestones.
• Manages timely reporting of internal needs supporting client work to the appropriate CCRM manager for resolution.
• Represents CCRM and promotes its mission and capabilities to the CGT field through participation at conferences, symposia, other venues and customer visits, for both academic and industry partners.

Program Management/Tracking/Reporting

• Leads program management for iPSC, viral vector and immunotherapy  technology platforms, with support from a multidisciplinary team working in platform project management, development, operations, quality and supply chain.

• Implements best practices in:

• project management methodologies;
• internal and client management;
• contract management;
• communication to manage project scope, timelines, resources, deliverables, costs, revenue, margins, timely close-out of actions, identification of risks, issues and mitigation strategies; and,
• project close-out activities, including final reports, intellectual property summaries, and contract budget vs actual assessments.
• Works with the platform heads and platform project managers to build and improve technology development plans, addressing cross-platform collaboration and communication, and identifying gaps in planned work packages.
• Drives communication across the platform teams and senior management to improve collaboration and information sharing, maintaining stakeholder and client satisfaction.
• Collaborates as needed with key internal stakeholders and clients to create concise and accurate statements of work and change ordersthat reflect project needs, CCRM facility and personnel capabilities and resources, and precise timelines. Projects may be located at CCRM, OmniaBio, or partner sites.

Cross-Functional Team Management

• Ensures active participation of team members to progress technology development plans with technical, business development, legal, and project management teams to deliver their required scope of work, on time and within budget, working in a matrix team model.
• Supports the CDO and platform heads to plan and run cross-functional meetings  to ensure timely development and circulation of materials and minutes.
• Collaborates with the technology transfer, materials management, facilities, manufacturing and quality groups at CCRM.
• Facilitates positive team member interactions and manages conflict with minimal assistance.
• Collaborates closely with materials management, operations and quality groups to ensure appropriate resources (people, equipment and materials) are available to successfully execute internal and client requested projects.

General Responsibilities

• Communicates and implements CCRM’s vision, mission and overall direction within the technology platforms.
• Provides operational and strategic recommendations to CCRM leadership and platform teams, and leads efforts to define and document operational mechanisms and site policies.
• Leads or supports operational and strategic meetings at the senior leadership level to ensure alignment across the technology platforms, business units and companies.Provides regular updates on progress, successes and challenges in achieving goals and metrics to CDO, internal stakeholders, platform leads and other CCRM executives, as requested.
• Demonstrates the CCRM values of purpose, integrity, excellence, accountability and collaboration, and motivates others to do the same.

Qualifications:

• Bachelor of Science degree in life sciences, biotechnology or microbiology preferred.

• 7+ years of post-graduate experience engaged in leading projects in an academic or industry environment.
• Minimum of 3 years of experience in the following:

• R&D and/or GMP environment and/or a controlled production environment requiring standard operating procedures validation procedures, etc. in the CGT space.
• project management and client service.
• leading cross-functional teams to execute projects.
• Excellent organizational skills and attention to detail.
• Able to manage multiple projects and priorities within a cross-functional, fast-paced organization.
• Strong English written and oral communication, and strong interpersonal skills.
• Able to motivate and influence stakeholders and clients.
• Comfortable working with  stakeholders of diverse backgrounds and levels of seniority.
• Experience with software-based project management, presentation and communication tools.
• Excellent understanding of client needs and providing superior customer service.

Desired Characteristics:

• Sound knowledge of applicable regulatory frameworks and requirements for CGT and regenerative medicine, such as GMP, International Organization for Standardization, or medical device development.
• Strong working knowledge of GMP quality and operational management systems.
• Experience working in an operational role and managing teams.
• Independent, detail-oriented self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.
• Demonstrates initiative and the ability to deliver high-quality outcomes.
• Driven by understanding, meeting and exceeding customers’ expectations and requirements.
• Evidence of leading by example to proactively identify problems and areas for improvement.
• Able to take a collaborative approach to working with cross-functional teams, with good multicultural awareness.
• Project Management Professional certification an asset.
• Previous experience working with or in CCRM an asset.