AbCellera is an energetic, growing techbio company that breaks the barriers of conventional antibody drug discovery by integrating expert teams, technologies, and facilities with the data science and automation needed to propel antibody-based medicines from target to patients. We are seeking a highly motivated Head of Process Development (PD) to build and oversee key CMC functional areas, including Cell Line Development, Upstream & Downstream Process Development, Analytical Development and Pharmaceutical Sciences, for antibody drug development towards early phase submissions.
In this role, based in beautiful Vancouver, Canada, you will be responsible for creating an approach to CMC development that is deeply integrated with our discovery, development and manufacturing teams, as well as our partners, with the goal of producing better antibody therapeutics with precision and speed. You will have the freedom to innovate to advance AbCellera’s portfolio towards the clinic and create a legacy, both in our industry and in Canada.
We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!
How you might spend your days:
- Providing exceptional leadership to the PD team, including hiring, mentoring, and developing AbCellerites
- Setting direction and providing technical guidance to PD functions developing integrated strategies for rapid, robust and scalable process development, tech transfer and regulatory filings
- Championing, with the definition of a technology roadmap, the development and implementation of new technologies, methodologies, and systems to improve project execution, leveraging data to drive innovation in biologics development
- Working closely with Discovery, Development, Manufacturing, Quality and Partnering teams to establish efficient workflows that enable smooth transitions from lead panel of antibodies through to clinical manufacturing
- Working closely with project teams, as well as existing and prospective partners to develop collaborative, innovative CMC strategies for effective and rapid drug development.
- Working closely with Manufacturing Science and Technology groups to facilitate efficient and accelerated tech transfers to internal and external manufacturing facilities, and to partners.
- Supporting 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
- Providing technical leadership support to the cGMP manufacturing operations while working closely with Manufacturing, MSAT and Quality teams.
We’d like to hear from you if you have:
- A passion for developing people, and a proven track record establishing process development capabilities and building teams.
- 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.
- Strong communication, organizational and project management skills, and an innate ability to build relationships across teams.
- Experience establishing CMC resourcing strategies to support the advancement of a large portfolio of programs
- 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.
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.
- 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).
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