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.
As a part of our newly created CMC organization, you will support our new process development platform from the ground up, all while leveraging cutting-edge technologies. You will be part of a team with an audacious goal: to go from discovery to fill-finish in a year.
This role will support Technical Operations and provide statistical analysis for all the functional areas including process development, analytical, and formulation development, MSAT and manufacturing teams. The position will include assisting scientists and other professionals to develop experimental designs, analyze data while incorporating scientific judgment and support generating technical / regulatory reports.
We’d love to hear from you if:
- You are an innovator and ready to help new approaches to the discovery and development of therapeutics
- You have a strong desire to support early antibody discovery work by developing ways to improve and speed up the discovery to 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
How you might spend your days:
- Providing statistical expertise to CMC functional areas
- Supporting product and process monitoring in GMP manufacturing (integrating statistical and practical approaches for method qualification, method validation, and method changes)
- Supporting regulatory submissions and investigations
- Keeping current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities
- Providing statistical insights in drug approval applications and responding to FDA and other regulatory agencies queries
- Proposing experimental design strategies and analyses, performing statistical analyses, and collaborating to ensure the statistical integrity of data in development and GMP manufacturing, and CMC reports
Required qualifications and experience:
- M.S and 8+, or Ph.D. with 6+ years of relevant work experience in CMC Statistics and/or Bioinformatics (degree in statistics, applied mathematics, or a related field)
- Experience with SIMCA, JMP, Minitab or similar statistical software, SAS programming
- Experience with experimental design strategies and analysis, statistical process control (including advanced process controls) capability analysis, and other aspects of engineering statistics
- Superb oral and written communication skills, including presentation of complex data
- Strong interpersonal skills with the ability to work collaboratively as a member of cross-functional teams
- Excellent documentation and organizational skills
- Demonstrated leadership skills
What we offer
A generous compensation package including an equity stake in AbCellera’s success. Our headquarters are 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!
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.