Full-Time

Director/Senior Director

AbCellera Biologics

AbCellera Biologics

501-1,000 employees

Accelerates antibody drug discovery with data science

Data & Analytics
AI & Machine Learning
Biotechnology

$146,000 - $183,000

Equity, Annual Bonus

Senior, Expert

Vancouver, BC, Canada

Requirements
  • Master’s degree in Microbiology, Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
  • 15+ years experience within the Biopharmaceutical / device industry
  • 12+ years experience Quality Control experience within an FDA CBER/CDER and EMA regulated industry
  • 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
  • Excellent working knowledge of applicable industry regulations (FDA, EMA), guidance documents (e.g. ICH) and industry best-practices
  • 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
Responsibilities
  • 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

AbCellera stands out as a leader in the biotech industry due to its unique approach to antibody drug discovery, combining expert teams, advanced technology, and data science to expedite the process from target to clinic across various therapeutic areas. The company's competitive edge lies in its ability to enable swift progress, cost reduction, and problem-solving in drug development for both innovative biotechs and leading pharmaceutical companies. Furthermore, AbCellera's commitment to technical innovation is evident in its recent presentation of new data on two T-Cell Engager Programs at SITC 2023, demonstrating its active role in advancing the field.

Company Stage

Series A

Total Funding

$393.1M

Headquarters

Vancouver, Canada

Founded

2012

Growth & Insights
Headcount

6 month growth

-3%

1 year growth

16%

2 year growth

77%