Senior Director of Process Development

14 hours ago

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

We are seeking a highly experienced Senior Director of Process Development to join our team at AbCellera. As a key member of our Process Development team, you will be responsible for leading the development and implementation of robust and scalable processes for the expression, harvesting, purification, and formulation of recombinant monoclonal and bispecific antibodies.

Key Responsibilities
  • Provide exceptional leadership to the Process Development team, including hiring, mentoring, and developing team members.
  • Set direction and provide technical guidance to Process Development functions, developing integrated strategies for rapid, robust, and scalable process development, tech transfer, and regulatory filings.
  • Champion the development and implementation of new technologies, methodologies, and systems to improve program execution, leveraging data to drive innovation in biologics development.
  • Lead the development and implementation of a robust data strategy, leveraging data-driven insights to optimize process efficiency and product quality.
  • Work closely with Discovery and Development teams to establish efficient workflows that enable smooth transitions from lead panel of antibodies through to the clinic.
  • Provide technical leadership support to the cGMP manufacturing operations while working closely with Manufacturing, MSAT, and Quality teams.
  • Create and maintain detailed work plans, with coordinated scheduling of tasks and milestones to facilitate the execution of projects within Process Development.
  • Work closely with project teams, as well as existing and prospective partners to develop collaborative, innovative CMC strategies for effective and rapid drug development.
  • Work closely with Manufacturing Science and Technology groups to facilitate efficient and accelerated tech transfers to internal and external manufacturing facilities, and to partners.
  • Support essential CMC activities required for IND/CTA submissions, including providing oversight on authoring efforts for specific CMC sections of regulatory filings, and working closely with project teams, CMC Regulatory, and Quality to prepare for regulatory interactions and formal responses to inquiries.
Requirements
  • A Master's or Ph.D. degree in biotechnology, chemical/biochemical engineering, or another relevant life-science discipline with a minimum of 15 years of industrial experience in antibodies process development, and a minimum of 6 years in a leadership role.
  • Hands-on experience with the development of robust and scalable upstream and downstream processes for the expression, harvesting, purification, and formulation of recombinant monoclonal and bispecific antibodies.
  • A passion for developing people, and a proven track record establishing process development capabilities and building teams.
  • Experience in authoring Module 3 CTD sections of IND filings and familiarity with regulatory standards and guidance documents for all phases of development (preferred).
  • Experience supporting product-related inspections for US and foreign regulatory agencies (desirable).
  • Experience working with Contract Development and Manufacturing Organizations (desirable).
  • The ability to thrive in an agile, fast-paced environment with a high level of urgency and evolving priorities, and to apply pragmatic, risk-based decision making to the process development.
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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