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 over 400 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.
The Director, Downstream Process Development, will be responsible for building a team and 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 process development platform from the ground up, all while leveraging cutting-edge technologies. As you lead process development for 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:
- Establishing the overall strategy for downstream process development for therapeutic antibodies and other protein biologics
- Establishing and build the downstream process development organization
- Providing a beginning-to-end solution for all aspects of downstream process development. This includes establishing a platform process and an associated development approach that enables the ability to rapidly develop a process and transfer to the GMP manufacturing facility
- Building and operating this critical component in our full-stack drug development platform to fully enable our partners
- Working 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 Downstream Process 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 downstream process 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 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 Downstream Process Development teams/departments for monoclonal antibodies and other protein biologics
- Demonstrated expertise in developing downstream processes, including viral clearance strategies, for early-phase GMP manufacturing required; experience with both early-stage and late-stage process development a plus
- Demonstrated expertise in applying QbD principles to process development – notably, a development approach aligned with the FDA guidance on a prospective, risk-based, lifecycle approach to development
- Demonstrated expertise in supporting process transfer and scale-up to GMP manufacturing facilities
- 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.
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.