External Quality Drug Substance, Manager
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 External Quality Drug Substance, Manager will be responsible for the quality oversight of one or several Contract Development and Manufacturing Organizations (CDMO’s) in charge of development and manufacturing of monoclonal antibodies.
The role will be involved during all steps of the CDMO lifecycle: Selection, Qualification, Management and Decommission. The Manager, External Quality Drug Substance will conduct Quality oversight during all drug substance development steps including cell line development, toxicology batch manufacturing, analytical method verification/qualification, and clinical DS batch manufacturing and testing.
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 external quality assurance
- You are an outstanding communicator with external partners and a teammate
How you might spend your days
- Overseeing all the CDMOs subcontracted activities, such as Cell Banking preparation, Reference Standard, Reference Samples and Reference Material management, Manufacturing and testing operations
- Being accountable for CDMOs quality management activities including: Deviations, Change Management, Complaints, Batch Release
- Working with key stakeholder groups (e.g. Procurement, Operations, QC, Supply Chain, Process Development, Legal, Partners), for the Selection, Qualification and Management of CDMOs
- Negotiating and maintaining Quality Agreements between AbCellera and CDMOs
- Supporting CMC Regulatory submissions
- Representing Quality Assurance for Analytical and Technical transfers to / from the CDMOs
- Defining, monitoring and reporting quality performance metrics
- Ensuring implementation at the CDMO of a compliant Data management process and other AbCellera quality initiatives
- Performing quality risk assessments, developing mitigation plan and following-up on implementation
- Maintaining CDMO site readiness for Health Authority regulatory inspections & for AbCellera /partners/ 3rd parties audits
- Participating in on-site regulatory inspections and audits
- Reporting the Health Authority inspections and audits outcomes and ensure implementation of associated action plans
- Maintaining current knowledge of applicable Quality & Regulatory requirements and evolving trends and supporting the CDMO to meet these standards
Required qualifications and experience
- A Bachelors or Masters degree in a relevant discipline and 8+ years of GxP industry experience
- 5+ years of supplier/vendor 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
- Ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures
- A thorough understanding of drug substance development process and monoclonal antibody manufacturing processes and testing
- 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
At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.
We’re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. 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. We’re looking for someone like you to support and organize our efforts along the way.