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Lead Scientist in Pharmaceutical Innovation
3 months ago
About AbCellera
AbCellera is at the forefront of transforming antibody discovery, aiming to deliver superior medicines to patients more efficiently. Our innovative approach combines expert teams, advanced technology, and comprehensive facilities with data science and automation to expedite the journey of antibody-based therapies from concept to clinical application.
Position Overview
We are in search of a dedicated Lead Scientist to enhance our Formulation and Pharmaceutical Development team within the Process Development division at AbCellera. In this pivotal role, the Principal Scientist will spearhead the establishment of platforms and workflows for formulation and drug product development, as well as oversee clinical in-use studies.
Key Responsibilities
- Provide strategic, technical, and tactical leadership for the Formulation Development team.
- Develop strategies for antibody formulation and drug product processes, ensuring alignment with regulatory standards and business goals.
- Contribute to multiple projects as a subject matter expert while mentoring and coordinating resource support.
- Represent the formulation function on internal and external CMC teams, influencing product control strategies related to formulation and drug product development.
- Lead the interpretation of analytical results to understand antibody degradation pathways and devise strategies to enhance product stability.
- Conduct data review, analysis, and troubleshooting for results generated by internal and contract laboratories.
- Author and review technical reports and regulatory submissions.
- Streamline activities associated with various formulation technologies and data analysis strategies to reduce development timelines and enhance formulation quality.
- Build and manage partnerships across research, non-clinical, clinical, drug substance process development, analytical development, and quality assurance.
- Provide mentorship and training to junior staff members.
Qualifications
- Ph.D. with 10+ years of relevant experience, or M.Sc./B.Sc. with 15+ years of experience.
- Demonstrated leadership experience, particularly in mentoring and aligning team goals.
- Extensive knowledge of formulation, drug product, and in-use stability development for monoclonal antibodies or similar biotherapeutics.
- Expertise in biophysical or biochemical characterization of proteins and their degradation pathways.
- Experience in authoring drug product sections for regulatory filings (e.g., INDs, IMPDs) and familiarity with CMC regulatory requirements for biologics (FDA, EMA, ICH).
- Experience with late-phase formulation and drug product development; familiarity with BLAs is advantageous.
- Experience with laboratory automation is a plus.
- Strong problem-solving abilities and excellent communication skills.
- Familiarity with electronic lab notebooks and experimental data capture.
What We Offer
AbCellera offers a competitive salary range of CAD $110,000 - $173,000 annually, commensurate with your education and experience. In addition to base salary, we provide equity, an annual bonus based on team and company performance, and a 6% (non-match) RRSP contribution.
Employees benefit from a CAD $1,500 annual Active Lifestyle Allowance, vacation time, flexible work arrangements, professional development opportunities, and comprehensive health benefits. We prioritize scientific and technical mentorship and foster a community-oriented environment through teams and social groups.
This is an opportunity to engage in life-changing research and be part of a diverse, multi-disciplinary team committed to advancing therapeutic solutions.
