Development Manager Senior

2 weeks ago

Vancouver, Canada AbCellera Full time
p>AbCellera is breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. We are a team of scientists, engineers, creatives, and business professionals who believe that advancing science enhances lives. We have developed technologies to unlock high-value drug targets, including antibody-drug conjugates and T-cell engagers for cancer, and complex transmembrane proteins for indications such as metabolic and endocrine conditions, pain, and autoimmunity.We are looking for a Senior Director of Process Development (PD)

We are looking for a Senior Director 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. In this position, based in beautiful Vancouver, Canada, you will be responsible for creating an approach to antibody process development that is deeply integrated with our discovery, development and manufacturing teams to support the advancement of antibody programs towards the clinic.Setting direction, providing technical guidance to PD functions and developing integrated strategies for rapid, robust and scalable process development, tech transfer and regulatory filings

Championing the development and implementation of new technologies, methodologies, and systems to improve program execution, leveraging data to drive innovation in biologics development Leading the development and implementation of a robust data strategy, leveraging data-driven insights to optimize process efficiency and product quality Working closely with Discovery and Development teams to establish efficient workflows that enable smooth transitions from lead panel of antibodies through to the clinic Providing technical leadership support to the cGMP manufacturing operations while working closely with Manufacturing, MSAT and Quality teams Creating and maintaining detailed work plans, with coordinated scheduling of tasks and milestones to facilitate the execution of projects within PD 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

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