AbCellera is breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. We are a team of scientists, engineers, creatives, and business professionals who believe that advancing science enhances lives. We have developed technologies to unlock high-value drug targets, including antibody-drug conjugates and T-cell engagers for cancer, and complex transmembrane proteins for indications such as metabolic and endocrine conditions, pain, and autoimmunity.
We are looking for a Quality Operations Manager - Drug Substance (DS) who will be responsible for providing direct quality oversight for the Upstream and Downstream operations at AbCellera’s state-of-the-art Clinical Manufacturing facility. In this role, based in beautiful Vancouver, Canada, you will be responsible for overseeing DS operations and you will also play an important role in ensuring our products, processes and procedures meet the highest standards of quality and compliance.
How you might spend your days
- Providing quality oversight of Drug Substance (DS) manufacturing operations, including Solution Prep (Media and Buffer) Cell Expansion/Production, Clarification/Harvest, Purification, Bulk Filling/freezing and storage activities
- Managing the Quality processes, procedures, systems, standards, and tools to provide proper quality oversight of DS manufacturing operations, including the direct oversight of activities such as Contamination Control Strategy (CCS) development and product changeovers/line clearance, etc
- Reviewing GMP documents and raw data, including Executed Batch Records for compliance with applicable procedures and standards (incl. Data Integrity) and ensuring proper disposition of bulk Drug Substance
- Reviewing and approving engineering processes and providing continuous quality oversight of engineering functions
- Managing Quality events such as deviations and investigations (including product complaints), CAPAs, and change controls related to the DS manufacturing areas
- Ensuring appropriate risk management of manufacturing operations, including risk evaluation, mitigation, documentation and reporting
- Maintaining close collaboration with other Quality departments as well as other AbCellerites and in particular Manufacturing, MSAT, Supply Chain, Facilities & Engineering and Project Management
- Supporting the preparation, review and/or responses to Regulatory Health Authority submissions (CTA/IND, etc)
We’d love to hear from you if
- You have a Bachelor’s or Master’s degree in a relevant discipline and 8+ years of GxP industry experience
- You have a strong comprehension of current pharmaceutical regulations and guidances (FDA/Health Canada/EU/ICH) and regulatory expectations for Drug Substance
- You have a thorough understanding of biologically-derived Drug Substance manufacturing and testing processes
- You have strong experience with various software/databases such as, but not limited to, ERP, MES, eQMS and LIMS
- You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
What we offer
AbCellera’s hiring range for this role is $92,000 - $115,000 CAD annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, an annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.
We have a number of ways to support AbCellerites in maximizing their work-life synergy. You will have a $1,500 annual Active Lifestyle Allowance, annual vacation, the opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find abundant teams and social groups to build community and connections across AbCellera.
About AbCellera
AbCellera is a global company that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.
And it all starts with our team. We’ve built a place where people feel they are part of something bigger than themselves. A place that exists to push the limits of science and technology, and aims to bring better therapies to patients.
We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success.