Vice President of Process Development and Manufacturing

4 days ago


Vancouver, British Columbia, Canada Aspect Biosystems Full time $176,000 - $271,000
Job Summary

We are seeking a highly experienced and skilled Vice President, Medicine and Quality to lead the strategy and execution of process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics.

Key Responsibilities
  • Develop and execute process development and manufacturing strategies for stem cell culture, differentiation, and integration with biomaterials using our bioprinting manufacturing technology.
  • Lead a team of cross-functional stakeholders to drive strategic decisions into manufacturing execution.
  • Ensure efficient and compliant functioning of BTT manufacturing, including direct responsibility for biomaterial and cellular drug substances as well as BTT (i.e., drug product) manufacturing functions.
  • Author, review and/or approve process development/transfer/validation study protocols and reports to ensure high quality documentation to support regulatory filings.
  • Enable and communicate a site mission and the strategic direction, business goals, objectives, and priorities.
  • Ensure processes are transferred, and products are manufactured and delivered in a safe, timely, and financially responsible manner in compliance with FDA, Health Canada, and EMA regulatory requirements.
Requirements
  • PhD with 15+ years or MSc/BSc with 20+ years directly related experience in process development and manufacturing, with experience in cell therapy.
  • Solid performance in managing quality events, such as deviations, CAPA, change controls.
  • Knowledgeable about GMP requirements for biologic or cell manufacturing and experience writing or contributing to regulatory filings.
  • Experience with scaling manufacturing processes, operations, and activities.
  • Advanced knowledge of the drug development process and the interdependencies of individual development activities and projects.
Preferred Qualifications
  • Excellent planning and organizational skills, with the ability to balance production, development, and continuous improvement needs.
  • Ability to manage concurrent deliverables and work effectively in a dynamic, fast-paced environment.
  • Ability to successfully prioritize and manage competing demands.
  • Ability to refine project plan/timelines to meet critical milestones.


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