Senior Scientist, Pharmaceutical Development (CMC)
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 Process Development and Clinical Manufacturing of antibodies to bring therapies from idea to patients, faster.
We are seeking a highly motivated Senior Scientist to join the Pharmaceutical Development team within Process Development at AbCellera. In this capacity, the Senior Scientist will be responsible for. establishing platforms and workflows for formulation and drug product process development, and clinical in-use studies.
The successful candidate will act as a mentor to junior staff, likely growing and managing a team of direct reports. A comprehensive understanding of regulatory guidelines and the roles of the Pharmaceutical Development function in its context will significantly contribute to success in this role. Individuals who can easily translate business objectives into technical and tactical plans will likewise experience success in this position. The role will offer numerous opportunities for growth and development as we seek to build this functionality at record pace.
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 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.
How you might spend your days
- 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.
Required qualifications and experience
- 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.
- Experience with lab automation is a plus.
- 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
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.
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