Director, QC Analytical/Bio-Analytical
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 Director, QC Analytical / Bio-Analytical is responsible for overseeing all Analytical/Bio-Analytical testing requirements of a state-of-the-art Biologics Drug Substance (DS) and Drug Product (DP) clinical manufacturing facility. The QC Analytical/Bio-Analytical labs, operating within AbCellera’s Quality Control (QC) department, will support all in-process, release, and ongoing stability testing of early clinical-phase (Phase I/II) Therapeutic Monoclonal (Mab) and Bispecific Antibody (BsAbs) products. This position is responsible for establishing, operating, and maintaining GMP Compliant QC Analytical/Bio-Analytical laboratory facilities.
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 building dynamic new teams and capabilities that accomplish important goals
- You have a bias towards innovation over industry standards
- You are an outstanding communicator and teammate
- You demonstrate excellent problem-solving skills
How you might spend your days
- Overseeing day-to-day QC operations including Chemical Testing, Biological Testing, and Stability Testing areas, ensuring adherence to cGMP standards
- Determining QC layout, design, qualification, and operation to optimize lab usage through increased flexibility, reduced complexity, and assure compliance with cGMP
- Ensuring all lab facilities, utilities and equipment are designed and installed to be operated in a safe and effective manner and are compliant with applicable standards, and to drive innovation with new technologies
- Writing, reviewing, and/or approving SOPs, sampling plans, and protocols
- Ensuring QC lab facilities, utilities and equipment are designed and installed to be operated in a safe and effective manner and are compliant with applicable standards, and to drive innovation with new technologies
- Overseeing GMP clinical and commercial stability planning, execution, data analysis and data trending in support of product expiry/shelf-life determination
- Managing the Reference Standard/Materials and Raw Material/Component sampling testing and release programs
- Monitoring QC resource capacity planning. Manage the work so that the samples and analyzes are done on time and with the required level of quality
- Managing the Retain and Reference Samples program
- Leading, mentoring, and coaching staff, and establish effective performance management. Set and deliver on individual and team goals that support the department and site strategy
- Ensuring adequate management of QC related validations, transfers, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), CAPA, and Change Control activities.
- Preparing and review all types of analytical test protocols and reports to ensure all testing comply with applicable Pharmacopeial and cGMP guidelines
- Assuring ongoing readiness for regulatory inspection; interact with Regulatory agencies in support of inspections, participate in internal and external audits, and prepare responses to correspondence and findings
Required qualifications and experience
- Masters degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field. A PhD is highly desirable
- 12+ years of industry Quality Control experience within an FDA CBER/CDER or EMA regulated industry with expert working knowledge in at least one relevant QC department (e.g., Bioassay, Chemistry or Immunoassays technology)
- 6+ years experience building, leading, developing, coaching, and mentoring a cross-functional team
- Direct experience and knowledge in antibody CMC development, protein chemistry and/or molecular biology (Protein characterization and method development) is highly desirable
- Excellent working knowledge of applicable industry regulations (FDA, EMA), guidance documents (e.g. ICH) and industry best-practices (e.g. PDA technical Reports)
- Experience with implementation phase-appropriate QC management systems supporting CMC through IND/BLA in compliance with applicable regulations, guidelines, and industry best practices
- Excellent analytical and problem-solving skills
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.