Bioprinting Manufacturing Leader

1 month 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.

Key Responsibilities
  • Develop and execute strategic plans for process development and manufacturing, ensuring alignment with company objectives and regulatory requirements.
  • Lead cross-functional teams to drive strategic decisions into manufacturing execution, including process development, tech transfer, analytical development, and manufacturing.
  • Design and execute process development and manufacturing strategies for stem cell culture, differentiation, and integration with biomaterials using our bioprinting manufacturing technology.
  • 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.
  • Collaborate with senior leadership and internal stakeholders to generate and execute preclinical and clinical project plans.
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.
  • Proficiency with MS Office and utilization of PM software (Smartsheet or other Gantting software).


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