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Director of Advanced Process Development

2 months ago

Vancouver, British Columbia, Canada AbCellera Full time

About the Role

AbCellera is at the forefront of transforming traditional drug development, driving the evolution of antibody-based therapies from concept to clinical application. Our diverse team comprises scientists, engineers, creatives, and business professionals dedicated to enhancing lives through scientific advancement. We have pioneered technologies that unlock high-value drug targets, including antibody-drug conjugates and T-cell engagers for cancer, as well as complex transmembrane proteins for various conditions.

We are seeking a Senior Director of Process Development to lead and manage critical CMC (Chemistry, Manufacturing, and Controls) functions, including Cell Line Development, Upstream and Downstream Process Development, Analytical Development, and Pharmaceutical Sciences. This pivotal role will involve creating a cohesive strategy for antibody process development that seamlessly integrates with our discovery, development, and manufacturing teams, facilitating the progression of antibody programs toward clinical trials.

Key Responsibilities

  • Deliver exceptional leadership to the Process Development team, focusing on recruitment, mentorship, and professional growth of team members.
  • Establish strategic direction and provide technical expertise to PD functions, developing integrated approaches for efficient, scalable process development, technology transfer, and regulatory submissions.
  • Advocate for the adoption and implementation of innovative technologies and methodologies to enhance program execution, utilizing data to foster advancements in biologics development.
  • Lead the formulation and execution of a comprehensive data strategy, employing data-driven insights to optimize process efficiency and ensure product quality.
  • Collaborate closely with Discovery and Development teams to create streamlined workflows that facilitate the transition of antibody leads into clinical settings.
  • Offer technical leadership to cGMP manufacturing operations, working in tandem with Manufacturing, MSAT, and Quality teams.
  • Develop and maintain detailed project plans, coordinating task schedules and milestones to ensure successful project execution within Process Development.
  • Engage with project teams and potential partners to devise collaborative and innovative CMC strategies for effective and expedited drug development.
  • Work alongside Manufacturing Science and Technology groups to ensure efficient and accelerated technology transfers to both internal and external manufacturing sites.
  • Support essential CMC activities for IND/CTA submissions, overseeing the preparation of specific CMC sections of regulatory filings and collaborating with project teams, CMC Regulatory, and Quality to prepare for regulatory engagements.

Qualifications

  • A Master's or Ph.D. in biotechnology, chemical/biochemical engineering, or a related life-science discipline, with a minimum of 15 years of industry experience in antibody process development, including at least 6 years in a leadership capacity.
  • Proven hands-on experience in developing robust and scalable upstream and downstream processes for the expression, harvesting, purification, and formulation of recombinant monoclonal and bispecific antibodies.
  • A passion for talent development, with a demonstrated history of establishing process development capabilities and building high-performing teams.
  • Experience in authoring Module 3 CTD sections of IND filings and familiarity with regulatory standards and guidance documents across all development phases is preferred.
  • Experience in supporting product-related inspections for both US and international regulatory agencies is desirable.
  • Experience collaborating with Contract Development and Manufacturing Organizations is advantageous.
  • Ability to thrive in a dynamic, fast-paced environment with shifting priorities, applying pragmatic, risk-based decision-making to process development.

What We Offer

AbCellera provides a competitive compensation range for this role, along with equity options, an annual performance-based bonus, and a 6% (non-match) RRSP contribution. Additional benefits include a CAD $1,500 annual Active Lifestyle Allowance, vacation time, flexible work arrangements, opportunities for professional development, and comprehensive health benefits. We prioritize scientific and technical mentorship and foster a community-oriented environment through team-building and social initiatives.

About AbCellera

AbCellera is a global leader in discovering and developing antibody-based therapies that enhance the quality of life for individuals. Our mission is to deliver innovative medicines to patients by advancing our internal pipeline and collaborating with partners who possess groundbreaking science or technology.

Our success is driven by our team—a collective of passionate individuals committed to pushing the boundaries of science and technology to provide better therapeutic options for patients.