Director, Assay 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 optimal lead antibodies that can be developed with unmatched precision and speed 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 are expanding our capabilities to include CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.
This role will work closely with Analytical Sciences and the Quality organization to develop in vitro potency assays to support AbCellera’s complex antibody programs in the process development and Manufacturing setting. You will be responsible for establishing a long-term vision for the Potency Assay Development department, providing technical, and managerial guidance as well as mentoring and growing the staff in the department. This individual will play a strategic role, and together with the Technical Operations (TO) senior leadership will establish platform technologies to support AbCellera’s programs and guide the potency group to perform essential supporting activities such as process and product characterization, comparability, and control strategy.
We’d love to hear from you if
- You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
- You are passionate about building dynamic new teams and capabilities that accomplish important goals
- You have a bias towards innovation over industry standards
- You are enthusiastic about applying your expertise in manufacturing operations
- You are an outstanding communicator and teammate
How you might spend your days
As the Head of Potency Assay Development Department and part of CMC leadership, your will:
- Provide strategic and technical guidance to a team of scientists with the development, optimization and qualification of potency assays based on in-vitro mechanism of action for lot release, stability-testing and characterization of antibodies for supporting clinical pipeline
- Provide exceptional leadership to the organization, including hiring, mentoring, and developing staff across the department
- Evaluate and implement relevant new technologies and strategies to assess AbCellera’s antibodies potency
- Author and review relevant CMC sections in support of global regulatory submissions for IND/CTA
- Work closely with Analytical Development and Quality to ensure effective assay development and transfer to Quality organization. Support a continuous improvement culture ensuring team members collaborate closely with Quality operations to define and document processes for efficient and appropriate assay development
- Core team member of CMC senior leadership, helping AbCellera to establish a vision for delivering our pipeline and bringing relevant and effective platform processes and technologies in the broader organization
Requires skills and experience
- 12+ years of experience in Bioassay development, optimization and qualification and deep understanding of in vitro mechanism of action of antibodies. Experience with assays such as cytotoxicity assays, binding assays (ELISAs, AlphaLISA and TR-FRET), flow cytometry, Octet, proliferation, phosphorylation and reporter assays etc are preferred
- 6+ years of experience leading a team within a biotech or pharmaceutical organization
- Outstanding technical acumen, operational understanding, and innovative mindset
- Strong passion to build, lead, and mentor a team with the opportunity to leave a lasting legacy on the team, and the organization
- Strong communication, teamwork and relationship building skills across the organization
- The ability to apply pragmatic, risk-based decision making to the operation
- Experience leading a site through quality audits and/or regulatory inspections
- Experience with CMC regulatory filings is strongly preferred
- A BS/MS/PhD in Biological Sciences or Engineering
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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