Head of Global MSAT (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 Head of Manufacturing Science and Technology (MSAT) will be responsible for building an exceptional team of scientists and engineers to meet the goal of managing all the tech transfers for our portfolio and establishing a tech transfer platform which enables Abcellera to quickly move from early phase to late-stage CMC activities in collaboration with our partners.
This role will work closely with Process Development to evaluate new technologies which can enable accelerated timelines without compromising product quality. You will be given the freedom to innovate and move at lightning speed to create a legacy in our industry, with the ultimate goal of implementing them in the manufacturing.
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
- Providing exceptional leadership to the organization, including hiring, mentoring, and developing staff
- As a a 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
- Working closely with various operating teams consisting of PD, Manufacturing, Supply Chain, Quality, and other functions as needed
- Overseeing technical transfer for manufacturing processes and analytical assays within Abcellera and externally in collaboration with CMO’s and AbCellera’s partners
- Initiating a continuous improvement culture ensuring team members collaborate closely with Quality operations to define and document processes for manufacturing operations
- Ensuring opportunities for improvement are continually evaluated and implemented
- Partnering with the Quality to manage batch documentation review, deviations and investigations, change controls, and CAPA’s, and to ensure the timely review and release of product from external manufacturing partners
- Partnering closely with Manufacturing and help monitor, assess and report GMP manufacturing performance; develop and implement continuous improvement projects to enhance manufacturing performance
- Collaborating with Development and manufacturing sites to assess manufacturability in order to anticipate potential risks and opportunities for improvements supporting next generation manufacturing processes
- Leading innovation of new platforms and technologies internally and with manufacturing partners.
- Supporting CMC sections of regulatory filings
Requires skills and experience
- 12+ years of experience in PD, MSAT or manufacturing of biologics in a GMP setting; experience with mAbs highly preferred
- 6+ year of experience leading a team within a biotechnology or pharmaceutical organization
- Outstanding technical acumen, operational understanding, and a deep understanding of manufacturing functions is desirable
- Strong leadership passion to build, lead, and mentor a team with the opportunity to leave a lasting legacy on the team, the organization, and the country
- A desire to innovate and push to do things differently
- Strong communication, teamwork and relationship building skills across the organization
- The ability to apply pragmatic, risk-based decision making to the operation
- Strong ability to be strategic
- Experience leading a site through Quality audits and/or regulatory inspections
- Experience with CMC regulatory filings
- 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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