Director, Downstream Process 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.
The Director, Downstream Process Development (CMC 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 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.
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
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
Required qualifications and experience
- 12+ 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
- 6+ years experience building, leading, developing, coaching and mentoring a cross-functional team
- 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 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.