AbCellera is breaking the barriers of conventional antibody discovery to bring better medicines to patients, sooner. Our engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic with precision and speed.
We are seeking a Lead, Pilot Plant Operations to provide technical and strategic leadership as we design, implement and operationalize a 200L scale pilot manufacturing facility to generate material for CMC development, including providing representative material of high quality for regulatory submission enabling GLP toxicology studies.
In this role, based in beautiful Vancouver, Canada, you will be responsible for creating an approach to Pilot Plant Operations that is deeply integrated with our discovery, development and manufacturing teams, as well as our partners, with the goal of producing better antibody therapeutics with precision and speed.
We’d love to hear from you if you:
- Have a passion for developing people and teams, and a proven track record establishing process development and/or manufacturing capabilities.
- Have experience in scale-up and operations to support robust upstream and downstream processes for the expression, harvest, purification, and formulation of recombinant monoclonal and bispecific antibodies, at scales of up to 200L.
- Thrive in a fast-paced environment with a high level of urgency and evolving priorities, and apply pragmatic, risk-based decision making to process development and manufacturing.
How you might spend your days:
- Championing high safety standards within the pilot plant.
- Providing strategic, technical and tactical leadership within the manufacturing, science & technology team through oversight of a 200L scale pilot manufacturing facility.
- Providing technical and scientific expertise and leadership for process optimization, scale-up, technology transfer and troubleshooting.
- Providing scientific leadership and project management for multiple early stage development projects.
- Detailed planning, coordination, implementation, tracking and communication to ensure material delivery whilst maintaining the production schedule for all technical Pilot Plant operations.
- Taking ownership and responsibility for the successful completion (as measured by product yield, quality & consistency, and the achievement of project timelines) of manufacturing campaigns.
- Providing a science-based approach for the evaluation and testing of new technologies / equipment to reduce cost of goods and streamline process development and manufacturing.
- Implementing and overseeing a robust equipment management and maintenance system, including oversight of and interaction with the site based support functions including the Facility Engineering and Metrology teams.
- Overseeing supply chain needs of the Pilot Plant, including working with materials management on ensuring critical supplies are available and in stock as well as, being the point person for new equipment or supplies required for new technology transfers into the Pilot Plant.
- Partnering closely with other stakeholders to enable technology transfers and scale-up to GMP manufacturing.
Required qualifications and experience:
- 10+ years of industrial experience in process development, manufacturing, and/or MSAT, ideally working with antibodies, and a minimum of 4 years in a leadership role.
- Post-secondary education in biotechnology, chemical/biochemical engineering, or another relevant life-science discipline.
- Experience in scale-up, technology transfer, batch documentation and data management.
- Demonstrated experience in leadership and managing direct reports including, developing and training teams to operate pilot scale manufacturing equipment.
- Strong pilot-scale process and product data analysis skills, and practical experience for the establishment of process and procedures for driving new investigational medicinal products forward.
- Familiarity with regulatory requirements as it pertains to CMC activities for biologics (FDA, EMA, ICH, etc). Experience authoring regulatory filings such as INDs, BLAs, IMPDs etc. would be advantageous.
- Demonstrated experience in manufacturing operations.
- Experience in manufacturing monoclonal and/or bispecific antibodies is highly desirable.
- Experience in material supply to support IND or other regulatory submission enabling GLP toxicology studies is highly desirable.
What we offer:
AbCellera’s hiring range for this role is $118,000 - $147,000, annually, commensurate with your education and job-related knowledge, skills, and experience. We base our salary ranges on localized market data ensuring competitive compensation. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and 6% (non-match) RRSP contribution.
At AbCellera, we have a number of initiatives to support AbCellerites in maximizing their work-life synergy. You will have a $1,500 annual active lifestyle allowance, annual vacation and company-wide office closures (a real value to all!), opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. Abundant team and social groups to build community and connections within AbCellera are a given.
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.