Project Manager, Cmc & Product Development

Position Overview:The Project Manager is responsible for planning and execution of cross-functional workstreams within the ReLiver program while supporting Morphocell’s advanced therapeutics pipeline. This role will develop and maintain integrated project plans across process development, product engineering, analytical development, manufacturing, Quality, Preclinical, and Regulatory activities, ensuring deliverables, dependencies, and timelines are clearly defined and effectively tracked.
Working closely with Technical Operations, ReLiver program leadership, and cross-functional teams, the Project Manager will facilitate project execution, monitor milestones and critical paths, proactively identify risks and potential delays, and coordinate appropriate follow-up and mitigation activities. The role will provide clear visibility into project progress and escale significant risks, dependencies, or decisions as appropriate.
The Project Manager will also coordinate activities with external partners, including CDMOs and CROs, and contribute to the continuous improvement of project management tools and processes as the organization grows. Success in this role requires strong organizational and project management capabilities, an understanding of biotechnology product development, and the ability to drive accountability and collaboration across teams in a dynamic start-up environment.
Key Responsibilities:Build, manage and maintain integrated cross-functional project plans and master timelines across process development, analytical development, drug substance/drug product manufacturing, pre-clinical, and regulatory activities.
Coordinate the execution of assigned projects by tracking milestones, deliverables, dependencies, and critical path activities to ensure timelines remain on track.
Facilitate cross-functional project meetings, document action items and key decisions, and follow up with stakeholders to ensure timely completion of deliverables.
Work closely with CMC, Quality, Regulatory Affairs, Pre-clinical, Manufacturing, and other functional teams to align project activities and resolve operational dependencies.
Proactively identify project risks, timeline delays, bottlenecks, and resource constraints, and support the development of mitigation plans with functional leads.
Monitor project progress and communicate clear, accurate status updates to project teams and leadership, highlighting key achievements, upcoming milestones, risks, and decisions requiring attention.
Support coordination of external CDMO/CRO activities by tracking project deliverables, timelines, and commitments in collaboration with Business Development and internal stakeholders.
Assist with the coordination of regulatory project timelines and submission-related deliverables in partnership with Regulatory Affairs.
Maintain project documentation, including timelines, risk registers, issue logs, action trackers, and decision records.
Contribute to the continuous improvement of project management tools, templates, workflows, and best practices to support efficient cross-functional execution.
Qualifications:Bachelor’s degree in life sciences, chemistry, biochemical/biological engineering, or a related scientific or technical discipline.
Advanced degree (M.S. or Ph.D.) in a relevant scientific or engineering field is considered an asset.
PMP certification or equivalent formal project management training is considered an asset.
Experience / Knowledge / Abilities:4–7+ years of relevant experience in CMC, technical operations, project management, or a related function within biotechnology, pharmaceutical, or cell and gene therapy organizations.
Experience coordinating cross-functional projects involving multiple scientific and technical workstreams, timelines, deliverables, and dependencies.
Demonstrated ability to develop and maintain integrated project plans, track milestones, identify risks and delays, and drive timely follow-up across functional teams.
Working knowledge of the drug development lifecycle, including CMC, process development, analytical development, manufacturing, pre-clinical, Quality, and Regulatory activities.
Experience supporting development programs progressing toward IND/CTA submissions and/or clinical manufacturing is considered an asset.
Experience working with external partners such as CDMOs, CROs, consultants, or other vendors, including tracking timelines, deliverables, and project commitments.
Exposure to regulatory submissions such as IND, IMPD, or equivalent is considered an asset.
Strong ability to facilitate cross-functional meetings, document decisions and action items, and ensure accountability for project deliverables.
Ability to identify project risks, dependencies, and resource constraints and work with functional leads to develop appropriate mitigation plans.
Strong organizational, communication, problem-solving, and stakeholder‑management skills, with the ability to influence and coordinate across functions without direct authority.
Comfortable working in a start‑up or small/mid‑size biotechnology environment with evolving priorities, ambiguity, and resource constraints.
Ability to prepare and communicate concise project updates to management and senior stakeholders.
Experience with cell therapy, gene therapy, regenerative medicine, or other advanced biologic modalities is strongly preferred.
Why Morphocell:Join a dynamic team of professionals committed to pushing the boundaries of cell therapy
Contribute to groundbreaking advancements in the field of biotechnology
Opportunity for personal and professional growth in a fast‑paced and collaborative environment
Competitive compensation package and benefits
Group medical, vision and dental insurance
RRSP matching contribution
If you are a highly motivated professional with expertise in cell therapy development and have a passion for driving innovation, we invite you to apply and be part of our mission to revolutionize patient care through cutting‑edge therapies.
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