Manager/Senior Manager, QA Operations, Drug Substance
AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are discovered with a discovery platform that integrates modern technologies from engineering, microfluidics, single-cell analysis, high-throughput genomics, machine learning, and hyper-scale data science. With over 400 AbCellerites and growing, we’re expanding our capabilities to include CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.
The Manager / Sr. Manager, Quality Operations - Drug Substance (DS) will be responsible for providing direct quality oversight for the Upstream and Downstream (Cell Culture through Bulk Filling) operations at AbCellera’s state-of-the-art Clinical Manufacturing facility. As the responsible QA Manager overseeing all DS operations, you will play an important role in ensuring that our products, processes and procedures meet the highest standards of quality and compliance.
We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!
We’d love to hear from you if
- You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
- You are passionate about working with dynamic new teams and capabilities that accomplish ambitious goals
- You are enthusiastic about applying your expertise in quality assurance
- You are an outstanding communicator with external partners and a teammate.
How you might spend your days
- Lead the QA Operations team in charge of 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.
- Manage 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.
- Review 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.
- Manage Quality events such as Deviations /Investigations (incl. Product Complaints), CAPAs, and Change controls related to the DS manufacturing areas.
- Ensure appropriate risk management of manufacturing operations, including risk evaluation, mitigation, documentation and reporting.
- Monitor and report department KPI/metrics for the purpose of driving Continuous Improvement.
- Maintain close collaboration with other Quality departments, such as Quality Control, Quality Systems, Supplier Quality, QA Validation and QA for QC.
- Support the preparation, review and/or responses to Regulatory Health Authority submissions (CTA/IND, etc)
- Maintain site readiness and actively participate in Regulatory inspections / company audits and department related actions. Monitor and ensure timely implementation of associated action plans.
- Maintain current knowledge of applicable Quality & Regulatory requirements and evolving trends.
Required qualifications and experience
- A Bachelors or Masters degree in a relevant discipline and 8+ years of GxP industry experience
- 5+ years of quality management leadership experience in a GxP regulated environment such as pharmaceuticals, biotechnology or equivalent
- Strong comprehension of current pharmaceutical regulations and guidances (FDA/Health Canada/EU/ICH) and regulatory expectations for assigned function
- Thorough understanding of biologically-derived Drug Substance manufacturing and testing processes
- Strong experience with various software/databases such as, but not limited to, ERP, MES, eQMS and LIMS
- Excellent communication and presentation skills with an ability to adjust to both technical and non-technical audiences
- Results oriented, and able to effectively execute on projects with minimal supervision