Vital Bio

Project Manager, Manufacturing Operations

Vital Bio

full-time

Posted on:

Origin:  • 🇨🇦 Canada

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Job Level

Mid-LevelSenior

Tech Stack

PMP

About the role

  • Facilitate and drive the execution of manufacturing-focused development, design transfer, and facility expansion projects from initiation through commercialization.
  • Manage weekly task execution, project controls, and KPI tracking to ensure projects meet scope, schedule, and budget.
  • Spearhead cross-functional teams spanning manufacturing engineering, assay development, consumable and hardware design engineering, manufacturing, facilities, quality, supply chain, and service.
  • Oversee project readiness for design transfer to manufacturing, managing the DMR, ensuring BOM accuracy, procedure readiness, and production documentation is complete.
  • Collaborate with manufacturing engineering and operations to develop manufacturing processes, establish production activities and material flow, implement equipment and tooling, and validate manufacturing processes in line with cGMP and ISO 13485 requirements.
  • Scope work, identify dependencies, and escalate budget or resource constraints promptly.
  • Establish dashboards and standard work processes for project management, monitoring and reporting.
  • Maintain close control of project deliverables through regular project meetings, dashboards and ad hoc standup meetings.
  • Work with project teams to apply Lean and Six Sigma principles into the development activities.
  • Ensure project visibility with clear reporting to leadership and stakeholders.
  • Develop and maintain detailed project schedules, dashboards, issue logs, and decision registers.
  • Create and execute risk management plans, monitoring risks throughout and implementing contingency actions when necessary.
  • Drive process improvement initiatives within the project execution framework to enhance efficiency and repeatability for future facility stand-ups.
  • Coordinate with suppliers, contractors, and external partners to ensure equipment commissioning, validation, and readiness for product build.

Requirements

  • Bachelor’s or higher degree in Engineering, Manufacturing, Business Administration, Life Sciences, or a related field.
  • 5+ years of project management experience in medical devices or other regulated manufacturing industries, with direct involvement in facility start-up or expansion projects.
  • Strong understanding of design transfer, manufacturing operations, and production ramp-up in a cGMP environment.
  • Experience with ISO 13485, FDA QSR, and other relevant regulatory requirements.
  • Hands-on experience in supply chain coordination, equipment installation, process validation, and manufacturing readiness.
  • Excellent organizational skills, attention to detail, and ability to manage multiple workstreams concurrently.
  • Strong communication skills with proven ability to collaborate with technical and non-technical stakeholders.
  • Proficiency in project management tools such as Smartsheet, MS Project, JIRA, MIRO, or FigJam.
  • Prior experience launching greenfield or brownfield manufacturing facilities (preferred).
  • Background in hardware, software, and reagent integration in a regulated environment (preferred).
  • PMP certification or willingness to pursue (preferred).
  • Knowledge of Lean, Six Sigma, and process optimization methodologies (preferred).
  • Experience managing capital equipment projects and validation activities (preferred).
  • Flexible, hands-on mindset with a passion for problem solving in dynamic settings.