Working at the interface of computation, engineering, and biology, AbCellera is redefining the process of how drugs are discovered. We’ve developed an AI-powered technology stack to discover antibodies and deliver large pools of curated candidates to our partners. And, we’re not stopping there. With nearly 300 AbCellerites and growing, we’re expanding our capabilities to include internal CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.
This role, Director, Analytical & Formulation Development, will be responsible for building a team and designing facilities to meet an audacious goal: to go from Discovery to fill-finish in a year. You will be given the freedom to move at lightning speed to create a legacy in our industry.
We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be 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!
As a key leader within our newly created CMC organization, you will have the exciting opportunity to build our new analytical & formulation development platform from the ground up, all while leveraging cutting edge technologies. As you lead the development of analytical methods to support the development of therapeutic candidates that will be produced in our new GMP facility, 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 will build our capacity to support our partners’ rapid transitions from target identification to clinical testing across therapeutic areas including oncology, inflammation, cardiovascular disease, pain, neurodegeneration, and more.
How you might spend your days:
- Establish the overall strategy for all aspects of analytical and formulation development for therapeutic antibodies and other protein biologics
- Establish and build the analytical and formulation development organization
- Provide a beginning-to-end solution for all aspects of analytical and formulation development. This includes providing analytical support to the process development and the antibody discovery teams, leading method development for process & product characterization, and the development of release methods for raw materials, drug substance, and drug product
- Lead the development of all characterization and release assays across a number of analytical modalities (e.g., biochemical, molecular, and cell-based assays)
- Overseeing method transfer to and supporting method qualification by the QC organization
- Develop liquid formulations for drug substance and drug product
- Build and operate this critical component in our full-stack drug development platform to fully enable our partners
- Work closely with AbCellera leadership peers to develop an innovative approach to CMC development that is closely integrated with the antibody discovery and antibody characterization teams
- Training and mentoring the Analytical and Formulation Development Team
- Evaluating new technology and approaches to improve and invent new approaches to the discovery, development, and manufacturing of antibody therapeutics. This includes a desire for leveraging data science and AI
- Preparing regulatory documents and communicating with health authorities
- Continuously drive improvements to the established processes, increasing speed and efficiency while meeting regulatory requirements
We’d love to hear from you if:
- You are an innovator and ready to help develop new approaches to the discovery and development of therapeutics
- 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 are enthusiastic about applying your expertise in analytical development to revolutionize therapeutic development
- You are an outstanding communicator and teammate
Required qualifications and experience:
- A total of 10+ years of industry experience with a PhD in Biochemistry, Molecular Biology, Biochemical/Chemical Engineering, Bioengineering or similar is required. Strong candidates with BS or MS degrees may be considered with sufficient Process Development and leadership experience
- Demonstrated experience in establishing and running Analytical and Formulation Development teams/departments for monoclonal antibodies and other protein biologics
- Demonstrated expertise in developing characterization and release methods for early-phase GMP manufacturing required; experience with both early-stage and late-stage development a plus
- Preferred experience with implementing Process Analytical Technology (PAT) or similar innovative approaches to using analytics to guide development and improve manufacturing
- Demonstrated expertise in supporting method transfer to and qualification by QC
- Experience in managing and mentoring a productive team of scientists & engineers
- Deep knowledge of global regulatory expectations for the development of protein biologics, including experience supporting INDs, CTAs, and other regulatory filings. Direct experience interacting with regulatory agencies and health authorities desired
- Strong interpersonal skills with the ability to work collaboratively as a member of cross-functional team
- Excellent documentation and organizational skills
- Superb verbal and written communication skills, including public presentation of complex data
At AbCellera, we’re solving tough problems and creating innovative solutions from the ground up - custom immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - revolutionizing how our scientists can mine natural immune systems to discover new antibody therapies, and the scale at which they can do it. This is life-changing research and you could be a part of it.
You’ll join a diverse team of scientists, engineers, software developers, data scientists and business professionals - all working together to bring better therapies to patients. Last year, AbCellera was named to Fierce Biotech’s Fierce 15 list, and received three Fast Company awards, including the Most Innovative Team of the Year for 2020 and Best Workplace for Innovators.
We’re a growing company with a high-throughput tech stack and the drive to be the best in the industry. This isn’t just about having the best technology, it’s also about having efficient and seamless operations based on teamwork and cutting-edge tools. We know we need a world-class team of visionaries and innovators across the entire organization. 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, nurture, and organize our efforts along the way.
AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce costs, and tackle the toughest problems in drug development.
Please submit your application through our website and refer to Job ID 21172. We apologize in advance, but we receive a large volume of applications and are only able to contact those who are selected for an interview.