Senior/Principal Scientist, Pharmaceutical Development Expert

4 weeks ago

Vancouver, British Columbia, Canada AbCellera Full time

At AbCellera, we are breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. Our team of scientists, engineers, creatives, and business professionals 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 seeking a highly motivated Senior/Principal Scientist to join the Formulation and Pharmaceutical Development team within Process Development at AbCellera. In this capacity, you will be responsible for establishing platforms and workflows for formulation and drug product process development, and clinical in-use studies. You will act as a mentor to junior staff, growing and managing a team of direct reports.

Key Responsibilities

  • Providing strategic, technical and tactical leadership for the Formulation Development team
  • Developing antibody formulation and drug product process development, and clinical in-use compatibility strategies in alignment with regulatory guidelines and business objectives
  • Contributing to multiple concurrent projects either directly as a subject matter expert or through mentoring and coordinating resource support
  • Representing the formulation function on internal and external CMC teams; contributing to the product control strategy as it relates to formulation and drug product development
  • Providing leadership on interpretation of analytical results to understand antibody degradation pathways and developing strategies to maximize product stability
  • Providing functional area data review, analysis, and troubleshooting for data generated by internal and contract labs
  • Authoring and reviewing technical reports and regulatory submissions
  • Streamlining the activities associated with a wide variety of formulation technologies and data analysis strategies to shorten development times and improve the quality of formulations being delivered
  • Building and managing partnerships with research, non-clinical, clinical, drug substance process development, analytical development, and quality
  • Providing support, mentorship, and training to junior staff

Requirements

  • You have a strong desire to support antibody development work by innovating ways to improve and speed up the CMC development to GMP manufacturing paradigm
  • You are ready to revolutionize therapeutic development and move at lightning speed to create a legacy in our industry
  • You hold a Ph.D. and 10+ years of experience, M.Sc. or B.Sc. and 15+ years of experience in formulation, drug product and in-use stability development with monoclonal antibodies or related biotherapeutic antibodies
  • You have proven experience leading a team including mentoring, team professional development and goal alignment with and across teams
  • You have expertise in biophysical or biochemical characterization of proteins and degradation pathways
  • You have experience authoring drug product sections of regulatory filings such as INDs, IMPDs, etc. and familiarity with regulatory requirements (FDA, EMA, ICH, etc)
  • You have a passion for science with a motivation for making contributions in a team environment
  • You thrive in a fast-paced environment and are able to balance multiple projects and challenging priorities

What We Offer

AbCellera's hiring range for this role is CAD $110,000 - $173,000 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, 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.

About AbCellera

AbCellera is a global company that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.

And it all starts with our team. We've built a place where people feel they are part of something bigger than themselves. A place that exists to push the limits of science and technology, and aims to bring better therapies to patients.

We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success.

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