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, Validation will be responsible for building a team and assisting in the start-up of the manufacturing facility to help achieve AbCellera’s vision to be the best in the world from discover 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 team responsible for the design, construction, commissioning, qualification, validation, 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 validation 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 a key manufacturing leader in the establishment of the Validation Department for the new GMP Manufacturing facility and operation. This includes:
- Providing exceptional leadership to the organization, including hiring, mentoring, and developing staff
- Serving as a key member of the manufacturing team for the commissioning, validation, and start-up of a new GMP Manufacturing facility to produce antibody therapeutics. This includes:
- Hiring and leading the team members for validation department responsible for all aspects of commissioning, qualification, validation, and start-up of the new facility
- Working with AbCellera site leaders to help ensure facility design will meet all strategic requirements related to capabilities, scale, capacity, cost, and timeline
- Helping ensure 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)
- Designing and operating manufacturing process and 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 Validation department once the facility is online. This includes:
- Owning the AbCellera validation program in support of the following areas – Facilities, Manufacturing, Analytical Testing, Quality Control Testing, Computer Systems, Software, and Process Qualifications.
- Maintaining a validation program in compliance with regulatory and industry standards.
- Ensure the efficient and compliant execution of commissioning, qualification, and validation activities, inclusive of process validation and regulatory submission, for a new, clinical manufacturing facility.
- In collaboration with the Quality Assurance department, ensure that all activities are executed in compliance with regulatory guidelines.
- Lead contract staff in the development and execution of validation protocols.
- Ensure efficient cGMP processes and software systems such that the compliant delivery of product is optimizing delivery of product supply.
- Contribute to risk analysis and mitigation plans to ensure product quality.
- Work closely with cross-functional teams (e.g., development, manufacturing, quality and commercial) to meet product demand and phase appropriate cGMPs.
- Contribute to writing and review of regulatory filings.
- Utilize project management tools such as schedules, action lists, and clear scope definition to ensure the timely completion of qualification activities.
- Controls and monitors all costs, capacity planning and utilization to support the achievement of qualification plans within budget.
- Performs investigations and develops practical solutions in a team-based environment.
- Provides input to engineering projects (construction, equipment, process, continuous improvement activities to ensure compliance with validations and quality standards.
- Provide technical support to Manufacturing – troubleshooting and resolving process related issues.
- Provide direction from validation for process improvement and scale up projects.
- Manages, approves, and generates validation documentation including protocols, plans, reports, and addenda.
- Management of validation life cycle to ensure ongoing validated state of systems through oversight of the execution of validation studies for cleaning and equipment qualification as required.
- Responsible for the Master Validation Plan (MVP) and all related documentation.
- Set strategic and technical goals for the validation team to provide continuous improvement in the areas of equipment qualification, and computer validation driving policy to align with regulatory and industry expectations.
- Provide direction and set goals to ensure compliance with the Quality Management System for Validation ensuring a state of inspection readiness.
- Being a champion for innovation; working closely with AbCellera peers on the development and implementation of novel technologies and systems
- Promoting a progressive culture of World Class GMP Manufacturing Operations
- 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
- Ensuring the facility is designed and operated at a high-level of GMP compliance. This includes:
- Identifying and mitigating risks in the validation program 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 Validation program are aligned with regulations/guidance/expectations from global regulatory agencies, including Health Canada, FDA, and EMA.
- Providing senior leadership to ensure the Validation team is prepared for all quality audits by AbCellera partners and regulatory inspections by global regulatory agencies and that any findings are addressed promptly
- Supporting CMC sections of regulatory filings
Requires skills and experience
- 8-12+ years of equivalent experience in validation and or engineering in a pharmaceutical and/or Biologics area required.
- 4+ years of experience in a leadership role managing GMP Manufacturing Operations
- Demonstrated strong management and leadership skills in implementing program/organization strategies.
- Experience with defending a validation program with Boards of Health.
- Independent problem solving and the ability to drive a team to support an ongoing cGMP Operation.
- Outstanding technical acumen, operational understanding, and GMP compliance in building and managing the new GMP facility
- Detailed knowledge of ICH, FDA, EMA regulations for manufacturing of biologicals.
- Experience managing suppliers and 3rd party contract organizations.
- Experience managing an electronic validation system is preferred.
- Strong leadership passion to build, lead, and mentor a team with the opportunity to leave a 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
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.