Associate Director, External MSAT

2 weeks ago


Vancouver, British Columbia, Canada AbCellera Full time
About the Role

We are seeking a highly motivated and experienced Associate Director to join our External MSAT group at AbCellera. As a key member of our team, you will be responsible for delivering first-in-class and best-in-class therapies to patients with a focus on antibody-drug conjugates (ADCs) programs.

Key Responsibilities
  • Support external Contract Development and Manufacturing (CDMO) activities as an individual contributor for clinical manufacturing of ADC-conjugated biologics Drug Substance and Drug Product (liquid and lyophilized)
  • Serve as the Tech Ops CMC Lead for ADC platform programs and work closely with our process development team and external partners to forge CMC strategies
  • Develop and support CDMO selection and onboarding processes
  • Provide technical and scientific leadership relating to process development experimental plans and analysis of process data, process deviations, and product impact assessment
  • Review technical reports and master batch records to ensure successful process development and clinical manufacturing
  • Provide shop-floor support (person-in-plant) during tech transfer, validation studies and clinical manufacturing
  • Review data packages for regulatory submissions
Requirements
  • PhD in biotechnology, chemical engineering or a related field with at least 10 years of industry experience working with ADCs; candidates with an MSc and 15 years of relevant experience will also be considered
  • Good knowledge of structured methodologies for process design, scale-up/down models, process control strategies, process validation and continuous process verification
  • Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams
  • Experience working with CDMOs and in CMC regulatory filings
  • Strong communication, teamwork and relationship building skills across the organization
  • Ability to apply pragmatic, risk-based decision making with a strategic, hands-on detail-oriented approach
About AbCellera

AbCellera is a global company that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.

We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success.



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