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Senior Scientist, Pharmaceutical Development Expert
2 months ago
We are seeking a highly motivated Senior/Principal Scientist to join our 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.
Key Responsibilities- Provide strategic, technical, and tactical leadership for the Formulation Development team.
- Develop antibody formulation and drug product process development, and clinical in-use compatibility strategies in alignment with regulatory guidelines and business objectives.
- Contribute to multiple concurrent projects either directly as a subject matter expert or through mentoring and coordinating resource support.
- Represent the formulation function on internal and external CMC teams; contribute to the product control strategy as it relates to formulation and drug product development.
- Provide leadership on interpretation of analytical results to understand antibody degradation pathways and develop strategies to maximize product stability.
- Provide functional area data review, analysis, and troubleshooting for data generated by internal and contract labs.
- Author and review technical reports and regulatory submissions.
- Streamline 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.
- Build and manage partnerships with research, non-clinical, clinical, drug substance process development, analytical development, and quality.
- Provide support, mentorship, and training to junior staff.
- A strong desire to support antibody development work by innovating ways to improve and speed up the CMC development to GMP manufacturing paradigm.
- Ready to revolutionize therapeutic development and move at lightning speed to create a legacy in our industry.
- 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.
- Proven experience leading a team, including mentoring, team professional development, and goal alignment with and across teams.
- Expertise in biophysical or biochemical characterization of proteins and degradation pathways.
- Experience authoring drug product sections of regulatory filings such as INDs, IMPDs, etc., and familiarity with regulatory requirements (FDA, EMA, ICH, etc.).
- A passion for science with a motivation for making contributions in a team environment.
- Thriving in a fast-paced environment and able to balance multiple projects and challenging priorities.
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.
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.
