Position: Project Manager
enGene Inc. is a high growth biotechnology company developing a robust, proprietary non-viral vector platform to deliver genes to various epithelial tissues. The vector system can be administered to the intestine via the oral or enema route, or the bladder via instillation. enGene is developing its unique gut optimized gene delivery formulation into an orally available “Gene Pill™”, which has the potential to be a platform for oral delivery of a wide range of therapeutic protein drugs. The Company’s primary focus is to apply its technology to enable localized delivery of therapeutic proteins to the gut and other epithelial tissues for treating various disorders.
enGene Inc. is currently seeking a qualified and motivated candidate who will play a key role in the organization. The Project Manager provides project management support to the pre-clinical development department in the company. This role reports directly to the Chief Technology Officer, dotted line to the Chief Scientific Officer.
The candidate will work in a dynamic, fast-paced and highly collaborative environment, as well as perpetuate the company culture that promotes our values (Patient-focused, Integrity, Innovation and Teamwork).
The Project Manager will:
- Act as the primary point of contact for the project.
- Ensure pre-clinical (R&D) program management aspects are given thorough consideration to achieve timely delivery of results;
- Develop project scope, budgets, and timelines, and project status reports and validate that critical elements are given proper consideration during project planning;
- Manage projects to strategies, budgets and timelines.
- Initiate, review and approve (as appropriate) study plans, variations and communications.
- Monitor/evaluate/review the scientific performance of the study. Provide regular progress updates.
- Maintain accurate project information, formulations, and specifications.
- Work collaboratively with cross functional teams.
- Make recommendations regarding project scope changes, issues, and risk mitigation.
- Lead and facilitate project status meetings and collaborative project requirement discussions.
- Assist with and contribute to project policies and procedures, data management, file compilations, SOPs and protocols.
- Engage stakeholders in addressing issues relating to project status, deliverables, and milestones;
- In collaboration with the Finance team, write and manage necessary documents for investors and financial stakeholders.
- Explain scientific performance expectations to scientific staff and direct study teams at study initiation.
- Work collaboratively with project team members, and liaise with internal and external stakeholders to follow up on important actions to maintain effective communication
- Using the NAV system and in collaboration with R&D managers, manage and coordinate schedules across the departments, including lab scheduling and resource management.
- Promote effective teamwork among project team members within departments and resolve conflicts as needed.
- Consult with appropriate scientific staff on issues as they arise.
- Promote and implement a culture of project management.
- Perform other duties as assigned.
Required education experience and qualification
- M.Sc. in biochemistry, chemistry, chemical engineering, or related discipline.
- PMP Certification with 5 to 7 years of experience or, a minimum of 10 to 15 years’ experience in a highly-regulated environment, preference will be given scientific project management.
- Experience in managing projects in Drug Discovery up to pre-IND package submission is preferred
- Experience with Chitosan/DNA and Chitosan/siRNA complexes for gene delivery, nanoparticle preparation and characterization, formulation screening, and optimization for products with various therapeutic applications is strongly preferred.
- A proven ability to understand and assess business goals, risks, potential value, and global market and regulatory landscapes.
- Significant experience in project management techniques in complex projects, including resourcing and financial management.
- Skilled in data interpretation and report writing for studies.
- Proficient in MS Office (Word, Excel, Project, SharePoint, and Outlook) with the ability to learn new software quickly.
- Excellent verbal and written communication skills.
- Able to prioritize and be flexible, while maintaining efficiency.
- Detail conscious and result oriented with a level of professionalism, integrity and ethics.
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