Head of Formulation and Drug Product Development Expert

2 months ago


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

AbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As a key member of our Process Development team, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product development activities.

Key Responsibilities
  • Develop and implement a comprehensive strategy for formulation, drug product, and clinical in-use development for therapeutic antibodies
  • Lead the formulation and drug product team to deliver high-quality formulations and drug products for AbCellera's pipeline
  • Collaborate with cross-functional teams to support the advancement of antibody programs towards the clinic
  • Develop and maintain relationships with CMOs and CDMOs to ensure timely and cost-effective delivery of drug products
  • Provide strategic guidance to meet near and long-term clinical demands
  • Develop and implement workflows for screening and selecting lead antibody molecules with optimal developability and manufacturing properties
  • Prepare and submit regulatory documents and communicate with health authorities
  • Drive process improvements to increase speed and efficiency while meeting regulatory requirements
Requirements
  • PhD in a relevant scientific discipline or equivalent experience
  • 6+ years of experience in building, leading, and developing cross-functional teams
  • Experience in establishing and running a Formulation Development team for monoclonal antibodies and other protein biologics
  • Experience in establishing phase-appropriate first-in-human formulation development strategies
  • Experience in overseeing the execution of formulation and drug product development activities at CDMO partner sites
  • Experience in working closely with Quality teams to establish workflows that ensure compliance with industry standards
  • Deep knowledge of global regulatory expectations for the development of protein biologics
  • Experience in interacting with regulatory agencies and health authorities
  • Bias towards innovation and passion for building dynamic teams and capabilities
  • Strong self-motivation and ability to identify project needs and implement solutions
About AbCellera

AbCellera is a global company that discovers and develops antibody-based medicines to help people live longer, happier, and more productive lives. We prioritize teams and social groups to build community and connections across AbCellera.

We look for people with drive and energy, idealists who are passionate about advancing science and technology to bring better therapies to patients.



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