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, QC Microbiology is responsible for overseeing all facilities, utilities, and product/process related Microbiological testing requirements of a state-of-the-art Biologics Drug Substance (DS) and Drug Product (DP) clinical manufacturing facility. The QC Microbiology labs, operating within AbCellera’s Quality Control (QC) department, will support all environmental, in-process and release testing requirements for early clinical-phase (Phase I/II) Therapeutic Monoclonal (Mab) and Bispecific Antibody (BsAbs) products.
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!
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 an outstanding communicator and teammate
- You demonstrate excellent problem-solving skills
How you might spend your days
- Performing periodic reviews and write reports for the environment and utilities monitoring programs
- Preparing and reviewing all types of microbial test protocols and reports to ensure all testing comply with applicable Pharmacopeial and cGMP guidelines
- Assuring ongoing readiness for regulatory inspection; interact with Regulatory agencies in support of inspections, participate in internal and external audits, and prepare responses to correspondence and findings
- Enabling quality culture through active leadership and communication of the organization’s mission, ethics, business objectives, compliance requirements, and commitment to patients and product quality
- Ensuring adequate management of QC related validations, transfers, investigations related activities (deviations, OOS, OOE, OOT, CAPAs, trending), CAPA, and Change Control activities
- Providing microbiology expertise in case of deviation, investigation or change request
- Ensuring that data generated by QC operations complies with good documentation practices; oversee personnel and computerized systems to ensure data integrity
- Contributing positively to a strong culture of integrity and ethics in business
- Managing the department Capex, Opex + Consumables budgets
- Ensuring QC lab equipment is validated, maintained, and calibrated - as required.
- Supporting the preparation of CMC regulatory filings and submissions
- Developing a high performing QC management team, including the attraction, development, and retention of talent
- Leading environmental excursion investigations ensuring corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings
- Ensuring QC lab facilities, utilities and equipment are designed and installed to be operated in a safe and effective manner and are compliant with applicable standards, and to drive innovation with new technologies
- Writing, reviewing, and/or approving SOPs, sampling plans, and protocols
- Managing MCB/WCB Cell Banking preparation and qualification programs
Required qualifications and experience
- Bachelor's or Master’s degree in Microbiology and 12+ years of Quality Control experience within an FDA CBER/CDER or EMA regulated industry with expert working knowledge of QC Microbiology program requirements. A PhD is highly desirable.
- 6+ years experience building, leading, developing, coaching, and mentoring a cross-functional team
- Direct experience and knowledge of aseptic processing, environmental/utility monitoring, clean room qualification, and microbiological testing required
- Excellent working knowledge of applicable industry regulations (FDA, EMA), guidance documents (e.g. ICH) and industry best-practices (e.g. PDA technical Reports)
- Experience with implementation phase-appropriate QC management systems supporting CMC through IND/BLA in compliance with applicable regulations, guidelines, and industry best practices
- Excellent analytical and problem-solving skills
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.