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, Process & Facilities Engineering (GMP Manufacturing) 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 innovate and 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!
You will be the senior engineering leader responsible for the design, construction, qualification, and operation of a new GMP manufacturing facility for the production of antibody therapeutics. The facility will produce API for global clinical studies and will be based around 2x2000 L single use bioreactors. You will be responsible for building an exceptional team and will be the senior engineering leader on-site when the facility is operational. In this role you will be a key leader at AbCellera responsible for delivering on a critical strategic program that will have a long-lasting legacy on the organization and Canada.
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 engineering
- You are an outstanding communicator and teammate
How you might spend your days
As a senior leader in the establishment of the Engineering Department for the new GMP Manufacturing facility and operation, you will be:
- Providing exceptional leadership to the organization, including hiring, mentoring, and developing staff
- Serving as the senior Engineering leader for the design, construction, and start-up of a new GMP Manufacturing facility for the production of antibody therapeutics. This includes:
- Working with AbCellera site leaders to ensure facility design will meet all strategic requirements related to capabilities, scale, capacity, cost, and timeline
- Ensuring facility is designed for the future, including the ability to implement innovative manufacturing approaches, add additional capacity, and/or extend into other competency areas (e.g., drug product manufacturing)
- Hiring and leading the Engineering department team members responsible for all aspects of facility design, construction, qualification, and start-up of the new facility
- Overseeing the design, specification (e.g., URS generation), sourcing, installation, and qualification for all GMP equipment
- Supporting the design and installation of all base-building utilities and other key non-GMP engineering systems
- Working closely with site leadership and Quality peers to develop and implement all GMP systems with an emphasis on paperless eSystems, including facility/equipment validation systems and facility/equipment monitoring systems
- Successfully bring the facility online for GMP manufacturing operations
- Being overall responsible for leading the site Engineering department once the facility is online. This includes:
- Hiring, leading and mentoring an exceptional team to run process and facilities engineering teams. This includes working to establish a powerful cultural that is integrated with AbCellera’s operations
- Developing and operating engineering systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Being a champion for innovation; working closely with AbCellera peers on the development and implementation of novel technologies and systems
- Working closely with TechOps peers in Process & Analytical Development to establish a paradigm for the evaluation and implementation of novel process equipment and approaches
- Promoting a progressive culture of World Class GMP Manufacturing Operations
- Ensuring the facility is designed and operated at a high-level of GMP compliance. This includes:
- Ensuring the facility and all GMP equipment is maintained in a qualified state
- Providing leadership and support to the manufacturing operation to resolve process and equipment issues
- Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effect therapies to patients
- Working closely with the site leadership, Manufacturing, and Quality peers to ensure the operation uses a risk-based approach to Quality
- Ensuring all aspects of the operation are aligned with regulations/guidance/expectations from global regulatory agencies, including Health Canada, FDA, and EMA.
- Providing senior leadership to ensure the facility and operation is prepared for all quality audits by AbCellera partners and regulatory inspections by global regulatory agencies and that any findings are addressed promptly
- Budgeting and planning, including:
- Working closely with AbCellera Business Development team to support establishment of global partnerships for development and implementation of novel process equipment and approaches
- Establishing and effectively managing operating budgets for the GMP Manufacturing site
Required qualifications and experience
- 12-15+ years of engineering experience in the development and manufacturing of biologics in a GMP setting
- 6+ years of experience in a leadership role managing Engineering teams supporting GMP Manufacturing Operations
- Outstanding technical acumen, operational understanding, and GMP compliance in building and managing the new GMP facility
- 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 knowledge of GMP systems and GMP manufacturing operations
- 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, yet hands-on and detail oriented
- Experience supporting site Quality audits and/or regulatory inspections
- A BS/MS/PhD in Chemical Engineering, Mechanical Engineering, or similar. Graduate degree preferred.
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.