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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly motivated Senior/Principal Scientist to join the Formulation and Pharmaceutical Development team within Process Development. 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...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleWe 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...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly motivated Senior/Principal Scientist to join the Formulation and Pharmaceutical Development team within Process Development. As a key member of the team, you will be responsible for establishing platforms and workflows for formulation and drug product process development, and clinical in-use studies.Key...
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Head of Formulation and Drug Product Development Expert
2 months ago
We are seeking an experienced and skilled professional to join our team as the Head of Formulation and Drug Product Development. As a key member of our Process Development team, you will be responsible for leading the formulation and drug product development activities for our therapeutic antibodies.
Key Responsibilities- Develop and implement the overall strategy for formulation, drug product, and clinical in-use development for therapeutic antibodies.
- Build and lead a team of scientists to oversee antibody formulation and CMC drug product development activities.
- Develop and implement workflows to deliver appropriate formulations and drug products for our pipeline.
- Support and provide strategic guidance to meet near and long-term clinical demands with a network of CMOs and CDMOs.
- Provide a beginning-to-end solution for all aspects of antibody formulation development.
- Work closely with our Technical Operations, Discovery, and Clinical Development teams to support the advancement of antibody programs towards the clinic.
- Develop and implement workflows for screening and selecting lead antibody molecules with optimal developability and manufacturing properties.
- Prepare regulatory documents and communicate with health authorities.
- Continuously drive improvements to established processes, increasing speed and efficiency while meeting regulatory requirements.
- PhD in a relevant scientific discipline, or BSc or MSc degree with sufficient 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.
We offer 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 also 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 we prioritize teams and social groups to build community and connections across AbCellera.
