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Senior Scientist
Pharmaceutical Development, CMC
Confirmed live in the last 24 hours
Vancouver, BC, Canada
Experience Level
  • You are an innovator and ready to help new approaches to the discovery and development of therapeutics
  • You have a strong desire to support antibody development work by innovating ways to improve and speed up the CMC development to GMP manufacturing paradigm
  • You are ready to revolutionize therapeutic development and move at lightning speed to create a legacy in our industry
  • You are an outstanding communicator and teammate
  • You are highly motivated and excited about the opportunity to work with an inspired team on challenging problems that matter
  • You have a passion for science with a motivation for making contributions in a team environment
  • You thrive in a fast-paced environment and are able to balance multiple projects and challenging priorities
  • Ph.D. and 5+ years of experience, M.Sc. and 8+ years of experience, or B.Sc. and 10+ years of experience
  • Experience with formulation and drug product development with monoclonal antibodies or related biotherapeutic antibodies
  • Expertise in biophysical or biochemical characterization of proteins
  • Familiarity with regulatory requirements as it pertains to CMC activities for biologics (FDA, EMA, ICH, etc). Experience authoring regulatory filings such as INDs, BLAs, IMPDs etc. Would be advantageous
  • Experience managing and mentoring junior scientists
  • A proven problem-solver and team player with strong written and verbal communication skills
  • Demonstrated leadership skills
  • Familiarity with electronic lab notebooks (Ex. Benchling), experimental data capture, and the associated 21 CFR part 11 compliance requirements
  • Providing technical and tactical leadership for the Pharmaceutical Development team
  • Responsible for formulation and drug product process development, and clinical in-use compatibility activities in alignment with regulatory guidelines (FDA, ICH, etc) and business objectives
  • Conducting biochemical and biophysical characterization and pre-formulation studies to support evaluation of preclinical drug candidates
  • Representing the formulation function on CMC teams; contributing to the product control strategy as it relates to formulation and drug product development
  • Scale-up and transfer of drug product processes to internal and external manufacturing sites
  • Contributing to multiple concurrent projects either directly as a subject matter expert or through coordinating resource support
  • Providing functional area data review and analysis; supporting technical development and troubleshooting for data generated by internal and contract labs
  • Authoring and reviewing technical reports and regulatory submissions
  • Drafting development strategies and work instructions to ensure that work is performed efficiently and in a scientifically sound manner
  • Streamlining the activities associated with a wide variety of formulation technologies to shorten development times and improve the quality of formulations being delivered
  • Building and managing partnerships with research, clinical, drug substance process development, analytical development, and quality
  • Providing support, mentorship, and training to junior staff
Desired Qualifications
  • Experience with lab automation is a plus
AbCellera Biologics
Company Overview
AbCellera Biologics is a biotechnology company that develops antibody therapeutics to improve patient outcomes.