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Vancouver, British Columbia, Canada AbCellera Full time{"title": "Senior Director of Process Development", "content": "About the RoleAbCellera is seeking a highly experienced Senior Director of Process Development to lead our Process Development team. As a key member of our CMC functional area, you will be responsible for creating an approach to antibody process development that is deeply integrated with our...
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Director of Antibody Process Engineering
3 months ago
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 of experts, including scientists, engineers, and business strategists, is committed to enhancing lives through scientific advancement. We have pioneered technologies that unlock valuable drug targets, such as antibody-drug conjugates and T-cell engagers for oncology, as well as complex transmembrane proteins for various health 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 leadership role will involve crafting a comprehensive strategy for antibody process development that seamlessly integrates with our discovery, development, and manufacturing teams, facilitating the progression of antibody programs into clinical stages.
Key Responsibilities
- Deliver outstanding 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 cohesive strategies for efficient and scalable process development, technology transfer, and regulatory submissions.
- Advocate for the adoption and execution of innovative technologies and methodologies to enhance program delivery, utilizing data to foster advancements in biologics development.
- Oversee the creation and implementation of a robust data strategy, harnessing data-driven insights to maximize process efficiency and ensure product quality.
- Collaborate closely with Discovery and Development teams to design effective workflows that ensure smooth transitions from lead antibody panels to clinical trials.
- Provide technical leadership to cGMP manufacturing operations, working in tandem with Manufacturing, MSAT, and Quality teams.
- Develop and maintain comprehensive project plans, coordinating tasks and milestones to support the successful execution of projects within Process Development.
- Engage with project teams and potential partners to formulate collaborative and innovative CMC strategies for 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 necessary for IND/CTA submissions, including overseeing the preparation of specific CMC sections of regulatory documents and collaborating with project teams and regulatory affairs to prepare for regulatory engagements.
Qualifications
- A Master's or Ph.D. in biotechnology, chemical/biochemical engineering, or a related life-science field, 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 strong commitment to team development, with a successful history of establishing process development capabilities and building high-performing teams.
- Experience in authoring Module 3 CTD sections of IND submissions and familiarity with regulatory standards across all development phases is preferred.
- Experience in supporting product-related inspections by US and international regulatory bodies is desirable.
- Experience collaborating with Contract Development and Manufacturing Organizations is advantageous.
- Adept at thriving 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 package for this role, including an annual salary aligned with your qualifications and experience. In addition to base pay, we offer equity options, an annual performance-based bonus, and a 6% RRSP contribution. You will also benefit from an 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 that encourages team building and social connections.
About AbCellera
AbCellera is a global leader in discovering and developing antibody-based therapies aimed at improving the quality of life for individuals. Our mission is to deliver innovative medicines to patients by advancing our internal programs and collaborating with partners who possess groundbreaking science or technology.
Our success is driven by our team, where individuals feel connected to a larger purpose. We strive to push the boundaries of science and technology to provide better therapeutic options for patients.
