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Director, External Manufacturing and Technology Operations
2 months ago
We are seeking a highly motivated and experienced professional to join our External MSAT group as an Associate Director, External Biologics Development. As a key member of our team, you will be responsible for delivering first-in-class and best-in-class therapies to patients with a focus on antibody-drug conjugates (ADCs) programs.
Key Responsibilities- Support external Contract Development and Manufacturing (CDMO) activities as an individual contributor for clinical manufacturing of ADC-conjugated biologics Drug Substance and Drug Product (liquid and lyophilized)
- Serve as the Tech Ops CMC Lead for ADC platform programs and work closely with our process development team and external partners to forge CMC strategies
- Develop and support CDMO selection and onboarding processes
- Provide technical and scientific leadership relating to process development experimental plans and analysis of process data, process deviations, and product impact assessment
- Review technical reports and master batch records to ensure successful process development and clinical manufacturing
- Provide shop-floor support (person-in-plant) during tech transfer, validation studies and clinical manufacturing
- Review data packages for regulatory submissions
- PhD in biotechnology, chemical engineering or a related field with at least 10 years of industry experience working with ADCs; candidates with an MSc and 15 years of relevant experience will also be considered
- Good knowledge of structured methodologies for process design, scale-up/down models, process control strategies, process validation and continuous process verification
- Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams
- Experience working with CDMOs and in CMC regulatory filings
- Strong communication, teamwork and relationship building skills across the organization
- Ability to apply pragmatic, risk-based decision making with a strategic, hands-on detail-oriented approach
AbCellera Biologics offers a competitive salary range of CAD $141,600 - $177,000 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.
