Job Summary
Reporting to the EVP Global Strategy & Technical Operations, the Senior Project Manager is accountable for execution and support of high value, complex & strategic capital projects across the Bimeda North America manufacturing site network. The manufacturing site network currently incorporates Bimeda MTC, Cambridge, Ontario, Bimeda Le Sueur, Minnesota and Bimeda Biologics, San Angelo, Texas.
The Senior Project Manager will lead Bimeda's strategic capital projects through their entire lifecycle, overseeing scope, budget, timelines, risk, and stakeholder communication, from initial planning to post-completion evaluation. Key responsibilities include developing the project charter and management plans, collaborating with cross-functional teams to define and manage project elements, ensuring quality and risk mitigation, managing budgets, and acting as the primary interface between the project and its stakeholders to achieve objectives. Prepare detailed capital project justification submissions for large-scale, multi-disciplinary projects, ensuring alignment with strategic business objectives.
Demonstrates an expert level of operational knowledge of pharmaceutical and/or biological manufacturing processes, systems and equipment.
Demonstrates a thorough understanding of good manufacturing practices (GMP), good documentation practices (GDP), regulatory guidance requirements, safety and environmental controls.
The Senior Project Manager will have experience operating within a PMO environment, using Project Management Software (PMS) applications to manage a portfolio of projects.
Role Specific Requirements
Project Leadership: Lead the end-to-end delivery of capital projects, including scope definition, planning, execution, monitoring, and closure.
Budget & Cost Control: Develop and manage project budgets, forecasts, and cost control systems, ensuring projects are delivered within approved financial parameters.
Scheduling & Resource Management: Build and manage detailed project schedules, ensuring the timely allocation of resources across engineering, construction, and validation teams
Risk Management: Identify, assess, and mitigate project risks; implement robust contingency and change management processes.
Compliance & Quality Assurance: Ensure all projects are executed in strict compliance with cGMP, FDA, Health
Canada, and other relevant regulatory and safety standards.
Stakeholder Engagement: Act as the primary liaison for senior leadership, site management, and external partners; provide regular updates and transparent reporting on project performance.
Vendor & Contractor Oversight: Lead the selection, negotiation, and management of engineering firms, contractors, and suppliers to ensure performance and accountability.
Commissioning & Validation: Oversee project handover, commissioning, qualification, and validation processes to ensure seamless integration into operations.
Continuous Improvement: Promote best practices, standardization, and lessons learned across the capital project portfolio to drive ongoing improvement in project execution.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Technical & Functional Expertise
- Strong knowledge of cGMP, FDA, Health Canada, and ICH guidelines as they relate to pharmaceutical manufacturing and facilities.
- Expertise in engineering design, construction management, commissioning, and validation of pharmaceutical facilities, utilities, and equipment.
- Proficiency in project management methodologies (PMP or equivalent certification preferred).
- Experienced in using Project Management Software for discrete project management and also as a PMO portfolio reporting tool.
- Experience with project controls (cost estimation, scheduling, risk management, and change management).
Leadership & Communication
- Ability to lead and influence cross-functional teams and external contractors in a matrixed environment.
- Exceptional stakeholder management skills, with the ability to communicate effectively at all organizational levels, including executive leadership.
- Demonstrated success in negotiating vendor contracts and managing third-party engineering and construction firms.
Operational & Strategic Skills
- Proven ability to balance strategic planning with hands-on execution in highly regulated environments.
- Strong analytical, problem-solving, and decision-making skills with a focus on risk mitigation and value optimization.
- Commitment to promoting safety, quality, sustainability, and compliance in all project activities.
Competencies required for the role
FOSTERING COLLABORATION/TEAMWORK - is the ability to work jointly with others or together especially in an
intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability
to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global
performance. Respects others.
PROCESS IMPROVEMENT - involves the business practice of identifying, analyzing, and improving existing processes to optimize performance.
EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen - help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others.
RESULTS ORIENTED - The ability to focus on the desired result of one's own department's work, setting challenging
goals, focusing on the goals, and meeting or exceeding them.
ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
Requirements
Essential:
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