AbCellera is breaking the barriers of conventional antibody discovery to bring better medicines to patients, sooner. Our engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic with precision and speed.
The Director/Senior Director, Quality Control (CMC/GMP) 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’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 enthusiastic about applying your expertise in quality control
- You are an outstanding communicator and teammate
How you might spend your days
- 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
Required skills and experience
- 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
- 6+ years experience building, leading, developing, coaching and mentoring a cross-functional team
- 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
- 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
What We Offer
AbCellera’s hiring range for this role is $146,000 - $183,000, annually, commensurate with your education and job-related knowledge, skills, and experience. We base our salary ranges on localized market data ensuring competitive compensation. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and 6% (non-match) RRSP contribution.
At AbCellera, we have a number of initiatives to support AbCellerites in maximizing their work-life synergy. You will have a $1,500 annual active lifestyle allowance, annual vacation and company-wide office closures (a real value to all!), opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. Abundant team and social groups to build community and connections within AbCellera are a given.
About AbCellera
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.
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