Head of Formulation and Drug Product Development Expert
2 weeks 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.
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As Head of Formulation and Drug Product Development, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product development...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As Head of Formulation and Drug Product Development, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product development...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As Head of Formulation and Drug Product Development, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product development...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As Head of Formulation and Drug Product Development, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product development...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As the Head of Formulation and Drug Product Development, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As the Head of Formulation and Drug Product Development, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As a key member of our Process Development team, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product development...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking an experienced Formulation and Drug Product Development professional to lead our team in developing innovative antibody-based medicines. As a key member of our Process Development team, you will be responsible for building and leading a team of scientists to oversee antibody formulation and CMC drug product development...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout AbCelleraAbCellera is a biotechnology company that specializes in the development of antibody-based medicines. We are a team of scientists, engineers, and business professionals who are passionate about advancing science to enhance lives. Our mission is to break the barriers of conventional drug development and propel antibody-based medicines from...
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