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Upper

Project Manager

The Project Manager is responsible for the oversight and management of multiple, commercially focused assay development programs for both external customers and internal IVD products. The role will facilitate the delivery of multiplexed assays and platforms through the product lifecycle of discovery, development, platform automation and verification/validation. Candidates will be required to manage at both the senior leadership team level as well as at the manager/bench level to uncover barriers to successful milestone achievements.

Lower
Job description
  • Provide clear direction and insight to the issues and barriers blocking milestone attainment across multiple projects and multiple disciplines
  • For each project have a clear and concise view of the next step’s activities and dependencies for successful completion of milestones
  • Provide senior leadership a continuous view of the project performance to schedule and risks and potential failure points that will require a strategic decision to resolve
  • For all other project risks that are deemed to not require strategic input have a plan of action to mitigate potential project slippage
  • For all projects be the “owner” of scope, manage the departmental leadership of each of the resources to ensure they have full view of their timelines, dependencies relative to each project and that they do not experience unmanaged “self-driven” scope creep
  • Assume the role of project scheduling for the manufacturing team so that they have a clear and visible understanding of what intermediate and final products are required by their various customers to allow projects to move ahead in a timely organized manner
  • Working with the senior leadership team to provide initial feedback on customer requirements and scope for each project that SQI wishes to submit a proposal on
  • Work as a team member to ensure that corporate goals and objectives are met
  • Creates and executes multiple and dependent project work plans and revises as appropriate to meet changing needs and requirements and manages day-to-day operational aspects of a project and scope
  • Writes ongoing commercial and program documents (IFU, PDR, DDP)
  • Ensures project documents are complete, current and stored appropriately

Qualifications

  • Position requires a degree in science, preferably biochemistry or molecular biology
  • 5-8 years as a project manager/project coordinator; preferably in the diagnostics or Pharma space
  • Experience in a diagnostic products regulated environment (FDA, Health Canada, CE)
  • Operational understanding of GLP and ISO quality systems
  • Experience with systems or automation technology in the laboratory setting
  • Needs to be able to drive design control deliverables from assay development to commercialization

Other required skills:

  • Strong organizational and written/verbal communication skills
  • Ability to communicate clearly and effectively with management, peers and subordinates
  • Strong organizational, leadership, and management skills
  • Excellent judgment, analytical and leadership skills required for risk mitigation
  • Strong understanding of immunochemistry methods, reagent process development and analytical skills
  • Must be able to communicate risk mitigation strategies in absence of all the required information
  • Must be analytical eg. able to build and review project timelines in a fast paced environment
  • Must be able to accomplish multiple tasks on tight deadlines

Apply

Please send your résumé and cover letter to resumes@sqidiagnostics.com, with the job title in the subject line.