Job ID: 220105
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 Associate Director, Downstream manufacturing will be responsible for building a team and assisting in the design of the manufacturing facility to help achieve AbCellera’s vision to be the best in the world from discovery to the clinic and 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!
In this role you will be a key member of the manufacturing operations leadership team responsible for 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 2×2000 L single use bioreactors. You will be responsible for building an exceptional team and will be the Downstream manufacturing leader on-site when the facility is operational. You will be a key manufacturing 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 manufacturing operations
- You are an outstanding communicator and teammate
How you might spend your days
As the leader in the establishment of the GMP Manufacturing Department for the new GMP Manufacturing facility and operation.
- Providing exceptional leadership to the organization, including hiring, mentoring, and developing staff
- Serving as a key member of the Manufacturing Operations leadership team for the design, construction, and start-up of a new GMP Manufacturing facility for the production of antibody therapeutics
- Working with AbCellera site leaders to ensure facility design will meet all strategic requirements related to capabilities, scale, capacity, cost, and timeline
- Ensuring the 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, leading and mentoring the team members for Downstream Manufacturing Operations including GMP production, materials management and manufacturing compliance. This includes working to establish a powerful culture integrated with AbCellera’s operations
- Designing and operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
- Working closely with site leadership and Quality peers to develop and implement all GMP systems with an emphasis on paperless eSystems
- Successfully bringing the facility online for GMP manufacturing operations
- Overall responsibility for leading the Downstream Manufacturing Operations department once the facility is online
- This role is responsible for managing an Downstream manufacturing department and ensuring execution of production plan, compliance initiatives, and project/campaign scheduling across multiple shifts
- 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 efficient process transfer and for SME technical support to manufacturing
- Promoting a progressive culture of World Class GMP Manufacturing Operations
- Ensuring the schedules of the people, facility, equipment, materials, and documents are established and maintained to support the capacity/throughput of the Downstream portion of the manufacturing process
- Provide managerial oversight and subject matter technical expertise (SME) to a group of individuals while also participating in on-the floor activities to ensure adequate execution of manufacturing campaigns in a multi-product GMP facility
- Lead adaptation of new technology into the area as appropriate
- Ensure timely issue escalation of issues to manufacturing leadership and cross-functional support team
- Lead cross functional teams to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
- Maintain and track KPIs for the assigned area
- Partner with other senior manufacturing leaders for the following:
- Design departmental training plan and manage execution
- Ensure inspection readiness of assigned manufacturing areas
- Drive/Sponsor improvements and efficiency initiatives
- Identifies opportunities to improve manufacturing process and practices
- Partner with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S, and VSM
- Ensuring the facility is designed and operated at a high-level of GMP compliance
- Identifying and mitigating risks in Downstream manufacturing operations that could negatively impact delivery of safe and effect therapies to patients
- Working closely with the site leadership and Quality peers to ensure the operation uses a risk-based approach to Quality
- Ensuring all aspects of the Downstream operation are aligned with regulations/guidance/expectations from global regulatory agencies, including Health Canada, FDA, and EMA
- Providing senior leadership to ensure the Downstream operation is prepared for all quality audits by AbCellera partners and regulatory inspections by global regulatory agencies and that any findings are addressed promptly
- Authoring, reviewing and approving controlled master documents including standard operating procedures, batch records, material specifications, and validation protocols
- Ensuring deviations from approved procedures are (1) accurately recorded in the original documentation and (2) are properly justified/investigated with respect to impact to the process and/or product
- Supporting CMC sections of regulatory filings
- Budgeting and planning, including:
- Helping to establish and effectively manage operating budgets for the GMP Manufacturing site
Requires skills and experience
- 8-12+ years of experience in manufacturing of biologics in a GMP setting
- 4+ years of experience in a leadership role managing Technical Operations, Process Development, and/or GMP Manufacturing Operations
- Outstanding technical acumen, operational understanding, and GMP compliance in building and managing the new GMP facility
- Significant knowledge of Downstream process techniques to support pre-clinical and clinical programs.
- 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 leading a site through Quality audits and/or regulatory inspections
- Experience with CMC regulatory filings
- A BS/MS/PhD in Biological Sciences or Engineering. Graduate degree preferred
About AbCellera
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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