Head of Formulation and Drug Product Development Lead

2 weeks ago


Vancouver, British Columbia, Canada AbCellera Full time
About AbCellera

AbCellera is a biotechnology company that specializes in the development of antibody-based medicines. We are a team of scientists, engineers, and business professionals who are passionate about advancing science to enhance lives. Our mission is to break the barriers of conventional drug development and propel antibody-based medicines from target to clinic.

We are seeking a highly experienced professional to lead our Formulation and Drug Product Development team. As a key member of our Process Development team, you will be responsible for overseeing the development of antibody formulations and drug products. Your expertise will be crucial in building and leading a team of scientists to deliver high-quality formulations and drug products to patients.

Key Responsibilities
  1. Develop and implement a comprehensive strategy for formulation, drug product, and clinical in-use development for therapeutic antibodies.
  2. Build and lead a team of scientists to develop and deliver antibody formulations and drug products.
  3. Collaborate with our Technical Operations, Discovery, and Clinical Development teams to support the advancement of antibody programs towards the clinic.
  4. Develop and implement workflows for screening and selecting lead antibody molecules with optimal developability and manufacturing properties.
  5. Prepare regulatory documents and communicate with health authorities to ensure compliance with industry standards.
  6. Continuously drive improvements to established processes, increasing speed and efficiency while meeting regulatory requirements.
Requirements
  • PhD in a relevant scientific discipline, or BSc/MSc with significant Process Development and leadership experience.
  • 6+ years of experience building, leading, and developing a cross-functional team.
  • Experience in establishing and running a Formulation Development team for monoclonal antibodies and other protein biologics.
  • Experience in establishing phase-appropriate first-in-human formulation development strategies, including stability evaluation, biophysical characterization, and clinical in-use evaluation.
  • Experience in overseeing the execution of formulation and drug product development activities at CDMO partner sites.
  • Experience in working closely with Quality teams to establish workflows that enable successful documentation, data capture, and data integrity, ensuring compliance with industry standards.
  • Deep knowledge of global regulatory expectations for the development of protein biologics, including experience supporting INDs, CTAs, and other regulatory filings.
  • Bias towards innovation over industry standards, keen to do things differently, and passionate about building dynamic teams and capabilities that accomplish important goals.
  • Strong self-motivation and ability to identify project needs and follow up with building and implementing solutions.
  • Experience with device development and/or antibody-drug conjugates.
What We Offer

AbCellera offers a competitive salary range of CAD $152,900 - $229,300 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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