Senior Director, Process Development and Innovation

7 days ago

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

We are seeking a highly experienced Senior Director to lead our Process Development team at AbCellera. As a key member of our leadership team, you will be responsible for building and overseeing our CMC functional areas, including Cell Line Development, Upstream & Downstream Process Development, Analytical Development, and Pharmaceutical Sciences.

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 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
  • 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.
  • Possession of 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).
  • 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.
What We Offer

AbCellera offers a competitive salary range of CAD $210,000 - $255,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.

You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you'll find we prioritize teams and social groups to build community and connections across AbCellera.

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