Senior Scientist, Analytical 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 CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.
We are seeking a highly motivated Senior Scientist to join the Analytical Development team within Process Development at AbCellera. In this capacity, the Senior Scientist will be responsible for establishing platform assays supporting quality control and process development. This will include both the development and qualification of high throughput and lot release assays designed to quantify process-related impurities typically observed during antibody production.
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 Impurities Assays 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 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 technical, tactical, and strategic leadership for the impurities assays function in Analytical Development
- Managing the development, characterization, and qualification of impurities assays (HCP, HC DNA, Residual Protein A, Insulin, etc) supporting bioprocess development
- Contributing to multiple concurrent projects either directly as a subject matter expert or through coordinating resource support
- Performing technology evaluation as it relates to impurities assays; managing the introduction of new technologies and strategies where appropriate (ELISA, qPCR, automation, etc)
- Aligning impurities assay development activities against regulatory guidelines (FDA, ICH, etc) and business objectives
- Representing the impurities function on CMC teams; contributing to the product control strategy as it relates to impurities analysis.
- Providing functional area data review and analysis; supporting technical development and troubleshooting
- Authoring and reviewing technical reports in support of regulatory submissions
- Building and managing partnerships across the Research and Quality organizations
- Coordinating co-qualification and technology transfer activities with Quality Control
- 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
- In-depth knowledge of immuno-assay development (Ex. ELISA), troubleshooting, and qualification
- Familiarity with regulatory requirements as it pertains to CMC activities for monoclonal antibodies (FDA, EMA, ICH, etc)
- Experience managing and mentoring a team of junior scientists
- Demonstrated proficiency with molecular biology techniques including 1D-/2D-Gel Electrophoresis, Western blotting, qPCR, etc
- Proficiency working with data acquisition platforms related to immunoassays (Ex. Softmax Pro)
- Experience with lab automation is a plus
- A proven problem-solver and team player with strong written and verbal communication skills
- Familiarity with electronic lab notebooks (Ex. Benchling), experimental data capture, and the associated 21 CFR part 11 compliance requirements
- Experience with CMC analytical development of monoclonal antibodies or related biotherapeutic proteins is a plus
- Knowledge of regulatory filings such as INDs, BLAs, IMPDs, etc would be advantageous.
- Understanding of regulatory requirements for biologics
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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