Senior/Principal Scientist, Pharmaceutical Development
2 weeks ago
Full-time Vancouver, British Columbia, Canada
AbCellera is breaking the barriers of conventional antibody discovery to bring better medicines to patients, sooner. Our engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic with precision and speed.
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, the Principal Scientist will be responsible for establishing platforms and workflows for formulation and drug product process development, and clinical in-use studies.
The successful candidate will act as a mentor to junior staff, likely growing and managing a team of direct reports. A comprehensive understanding of regulatory guidelines and the roles of the Pharmaceutical Development function in its context will significantly contribute to success in this role. Individuals who can easily translate business objectives into technical and tactical plans will likewise experience success in this position.
We'd love to hear from you if:
- You are an innovator and ready to help new approaches to the discovery and development of therapeutics
- 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 are an outstanding communicator and teammate
- You are highly motivated and excited about the opportunity to work with an inspired team on challenging problems that matter
- 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
How you might spend your days:
- 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
Required qualifications and experience
- Ph.D. and 10+ years of experience, M.Sc. or B.Sc. and 15+ years of experience.
- Proven experience leading a team is essential; specifically around mentoring, team professional development and goal alignment with and across teams
- In-depth knowledge of formulation, drug product and in-use stability development with monoclonal antibodies or related biotherapeutic antibodies
- 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 as it pertains to CMC activities for biologics (FDA, EMA, ICH, etc)
- Experience with late phase formulation and drug product development, authoring BLAs would be advantageous
- Experience with lab automation is a plus
- A proven problem-solver and team player with strong written and verbal communication skills
- Familiarity with electronic lab notebooks (Ex. Benchling) and experimental data capture
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, 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.
About AbCellera
At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You'll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.
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