Canada Req #196

Thursday, August 10, 2023

About OmniaBio:

OmniaBio Inc. is a contract development and manufacturing organization (CDMO) focused on cell and gene therapies from pre-clinical through to commercialization, and a subsidiary of CCRM. Benefitting from CCRM’s existing expertise, OmniaBio provides a continuum of advanced process and analytical development, and manufacturing capabilities, by enabling focused support for clients from early clinical phase to commercial supply needs. OmniaBio is built upon leadership in iPSCs, immunotherapy and LVVs. To be located at McMaster Innovation Park, less than one hour from the U.S. border, OmniaBio’s new commercial manufacturing site will anchor a biomanufacturing centre of excellence and will open with late clinical phase and commercial capacity in 2024 in a site totaling approximately 100,000 square feet. OmniaBio is supported by the Government of Ontario, via the Invest Ontario Fund. Please visit us at www.omniabio.com.

Position Summary:

As a Project Manager at OmniaBio, a subsidiary of CCRM, you will be part of a diverse bioengineering team working with the Centre for Advanced Therapeutic Cell Technologies (CATCT), the Centre for Cell and Vector Production (CCVP) and OmniaBio, focused on designing and implementing Research & Development and/or Good Manufacturing Practices (GMP) production projects within the cell and gene therapy, and regenerative medicine fields. You will apply project, client, and contract management expertise to ensure clients receive best-in-class customized services for their R&D, clinical study or commercial manufacturing and testing requirements. As a Project Manager working with cross-functional teams, you will be responsible for project scope, budget, task planning and prioritization to support the execution of services requested by R&D and/or GMP clients; including fee-for- service contract manufacturing, and other valuable service offerings to cell and gene therapy, and regenerative medicine.

Responsibilities:
Client Management/Engagement

• In collaboration with the business development team, support, lead, and/or organize internal and external client meetings to establish relationships and acquisitions for CCVP and OmniaBio services.
• Build and improve CCRM and OmniaBio project, client, and contract management tools.
• Maintain regular contact with active clients to ensure effective and timely communication and customer satisfaction.
• Manage timely reporting of client needs to the appropriate CCRM and/or OmniaBio leadership team(s) for resolution.
• Represent CCRM and OmniaBio and promote their mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues, and customer visits, for both academic and industry partners.

Project Management/Tracking/Reporting

• Project leadership in managing up to six or more projects of varying sizes with support from a multidisciplinary team working in operations, quality and supply chain.
• Implement 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, contract budget vs actual assessments.
• Drive communication across the project team and senior management to find cost-effective resolutions while maintaining customer satisfaction.
• Collaborate with the business development team and client contacts to create concise and accurate statements of work (SOW), which reflect the following: customer needs, the capabilities, and resources of the CATCT or CCVP facility and personnel, and precision timelines. Projects may be located at the CCRM, OmniaBio or the partner’s sites.

Cross-Functional Team Management

• Under a matrix team model, ensure active participation of team members to deliver their required scope of work, on time and within budget.
• Collaborate with the technology transfer, materials management, facilities, manufacturing and quality groups at CCRM and/or OmniaBio (including quality control, sterility assurance and quality departments).
• Facilitate positive team member interactions and manage conflict with minimal assistance.
• Collaborate closely with materials management, operations and quality groups to ensure appropriate resources (people, equipment and materials) are available to successfully execute client requested services.

General Responsibilities

• In collaboration with colleagues, assist in creating, communicating, and implementing CCRM’s vision, mission and overall direction within the business unit.
• Provide regular updates on progress, successes, and challenges in achieving goals and metrics to the Senior Project Manager and Chief Commercial Officer, and other CCRM and OmniaBio executives as requested.
• Demonstrate the CCRM and OmniaBio values of purpose, integrity, excellence, accountability, and collaboration, and motivate others to do the same.

Requirements:

• BSc in life sciences, biotechnology, or microbiology with 6+ years of post-graduate experience engaged in leading projects in an academic or industry environment. Masters with 4+ years of experience will also be considered.
• At least three years of experience as follows:
  • Working in an R&D and/or GMP environment and/or a controlled production environment requiring standard operating procedures (SOPs), validation procedures, etc.
  • Project management and client service.
  • Leading cross-functional teams to execute projects.
• Excellent organizational skills and attention to detail, while managing multiple projects and priorities within a cross-functional, fast paced organization.
• Strong English written and oral communication, and interpersonal skills.
• Ability to motivate and influence stakeholders and clients.
• Experience with software-based project management, presentation, and communication tools.
• Excel at understanding client needs and providing excellent customer service.

Desired Characteristics:

• Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, International Organization for Standardization (ISO) or medical device development.
• Experience or familiarity with cell and/or gene therapy and/or viral vector manufacturing.
• Experience working for a contract manufacturing organization (CMO) in a GMP facility.
• Strong working knowledge of GMP quality and operational management systems.
• Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.
• Demonstrated initiative and the ability to deliver high-quality outcomes.
• Driven by understanding, meeting and exceeding customers’ expectations and requirements.
• Leads by example to proactively identify problems and areas for improvement.
• Takes a collaborative approach to working with cross-functional teams, with good multicultural awareness.
• Project Management Professional (PMP) certification is an asset.