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 Senior Director, Quality Control will be responsible for building a team and designing quality systems to meet an audacious goal: to go from Discovery to fill-finish in a year. You will be given the freedom to move at lightning speed to create a legacy in our industry.
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 don’t yet have the joy of living in this beautiful area!
How you might spend your days:
- Providing exceptional leadership to the organization, including hiring, mentoring and developing staff.
- Building the QC organization (CMC/GxP) and ensuring that all team members have the appropriate level of education, experience and training to support their assigned job functions.
- Establishing, directing, coordinating and managing the reporting Quality Control (QC) functions (QC Microbiology, QC Analytical, QC Bio-analytical, Raw Material Testing/Release, DS/DP Testing/Release, Stability/Comparability, Cell Banking, etc.).
- Developing, administering and maintaining Quality Control related methods, procedures, specifications and activities ensuring the company’s processes and products are in compliance with applicable quality standards and requirements.
- Providing lifecycle management for the design, qualification, operation and ongoing review of CMC/GMP facilities, including associated digital Quality systems (e.g. ELN, LIMS, etc.) in accordance with applicable regulations and guidelines.
- Participating in the selection and governance/management of external vendors (e.g. External Testing Labs/CROs), including the oversight of all QC Tech Transfer activities.
- Collaborating with internal/external/partner cross-functional teams to ensure the timely and compliant progression of CMC/GMP projects.
- Authoring and reviewing CMC INDs, BLAs, and other relevant regulatory dossier sections and strategizing to support responses to regulatory questions during review period and product lifecycle.
- Leading the Quality Control department program through progression from lead candidate selection through pre-clinical, IND and/or commercial readiness (BLA) activities.
- Providing technical oversight and direction in the areas of Chemistry, Microbiology, Bioanalytical, Physical and/or Raw Material testing.
- Developing and implementing Quality Control, sampling and inspection procedures for the receipt and control of incoming materials.
- Implementing and managing in-process and final (bulk) product testing and acceptance (release/reject) activities and compliant reference and retain sample programs.
- Defining quality control standards and tests; specify test equipment, procedures and QC equipment qualification requirements.
- Implementing and managing the bioanalytical and microbiology QC methods and compendial methods required for the release and stability testing of raw material, in-process, and final (bulk) product.
- Performing the QC release function and establishing and managing the QC Reagent program.
- Managing QC Tech Transfer, QC Method Qualifications/Validations and Cell Bank qualification, testing and release programs.
- Executing and managing Stability and Comparability studies in accordance with applicable guidelines (e.g. ICH).
- Managing the deviations/OOS investigation procedure as it relates to QC testing activities and implementing phase-appropriate CAPA and change controls to drive continuous improvement.
- Establishing and maintaining test instrument calibration procedures,maintenance schedules and usage logs (as appropriate).
- Executing utility system and facility Environmental Monitoring (EM) qualification and ongoing monitoring programs.
- Developing, implementing and monitoring the QC Opex/Consumables and Capex budgets.
- Identifying, analyzing and reporting Quality Control department metrics.
We’d like to hear from you if you have:
- A Master’s degree in Microbiology, Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field. PhD is highly desirable
- 15+ years experience within the Biopharmaceutical / device industry. Previous experience within a Quality Assurance function is considered to be an asset.
- 12+ years experience Quality Control experience within an FDA CBER/CDER and EMA regulated industry with expert working knowledge in one or two QC departments (e.g., Microbiology, Bioassay, Chemistry or Immunoassays technology) including method qualification/validation.
- 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.
- Experience and passion to build, lead and mentor a cross-functional team with the opportunity to leave a lasting legacy on the team, organization and the country.Experience in leading, developing, coaching and mentoring a cross-functional team.
- The ability to develop an overarching CMC/GMP QC strategy and inspire a team to deliver upon AbCellera’s vision and goals.
- Demonstrated a strong Quality mindset and ability to influence across the entire organization.
- Experience in communicating and/or interacting with Regulatory Health Authorities in direct support of IND/BLA submissions and associated facility inspection activities.
At AbCellera, we’re solving tough problems and creating innovative solutions from the ground up - custom immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - revolutionizing how our scientists can mine natural immune systems to discover new antibody therapies, and the scale at which they can do it. This is life-changing research and you could be a part of it.
You’ll join a diverse team of scientists, engineers, software developers, data scientists and business professionals - all working together to bring better therapies to patients.
We’re a growing company with a high-throughput tech stack and the drive to be the best in the industry. This isn’t just about having the best technology, it’s also about having efficient and seamless operations based on teamwork and cutting-edge tools. We know we need a world-class team of visionaries and innovators across the entire organization. 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, nurture, and organize our efforts along the way.