Vice President of Process Development and Manufacturing

5 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 our process development and manufacturing activities for our pipeline of Bioprinted Tissue Therapeutics. This role requires a deep understanding of biopharmaceutical process development, cGMP manufacturing, and regulatory requirements associated with cell-based therapies and combination products.

Key Responsibilities
  • Oversee the process development and supply of therapeutic cells, biomaterials, and Bioprinted Tissue Therapeutic products
  • Provide strategic, efficient, high-quality leadership and technical expertise in the process development and manufacturing of cell-based combination products
  • Directly manage the Process Development and Manufacturing teams and be accountable for ongoing high-quality delivery or work and effectiveness of the teams
  • Forecast, schedule, and track all manufacturing activities to ensure timely disposition and accountability for Key Performance Indicators
  • Provide input to the overall Technical Operations strategies and operational planning
  • Liaise with various internal and external stakeholders to generate and execute preclinical and clinical project plans
  • 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
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
What We Offer

We offer a dynamic and fast-paced work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.



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