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Senior Manager, External Quality

AbCellera Biologics

AbCellera Biologics

Quality Assurance
Vancouver, BC, Canada
Posted on Tuesday, June 13, 2023

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 500 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 Senior Manager, External Quality will be responsible for the quality oversight of Contract Development and Manufacturing Organizations (CDMO) and Contract Laboratories organizations (CLO) in charge of development, manufacturing, and testing of monoclonal antibodies

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 have a strong leadership passion to build, lead, and mentor a team with the opportunity to leave a lasting legacy on the organization
  • 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 working with dynamic new teams and capabilities that accomplish ambitious goals
  • You are enthusiastic about applying your expertise in external quality assurance 
  • You are an outstanding communicator with external partners and a teammate

How you might spend your days

  • Providing exceptional leadership to the organization, including hiring, mentoring, and developing staff
  • You and your team will oversee a portfolio of CDMO/CLO providing activities such as development, manufacturing and testing 
  • You will be accountable for CDMO/CLO quality management activities including Deviations, Change Management, Complaints, Batch Release
  • Working with key stakeholder groups (e.g., Procurement, Operations, QC, Supply Chain, Process Development, Legal, Partners), for the Selection, Qualification and Management of CDMO/CLO
  • Negotiating and maintaining Quality Agreements between AbCellera and CDMO/CLO
  • Supporting CMC Regulatory submissions 
  • Representing Quality Assurance for Analytical and Technical transfers to / from the CDMO/CLO
  • Ensuring implementation at the CDMO/CLO of a compliant Data management process and other AbCellera quality initiatives
  • Performing quality risk assessments, developing mitigation plan and following-up on implementation
  • Maintaining CDMO/CLO site readiness for Health Authority regulatory inspections & for AbCellera /partners/ 3rd parties audits 
  • Participating in on-site regulatory inspections and audits
  • Reporting the Health Authority inspections and audits outcomes and ensure implementation of associated action plans 
  • Maintaining current knowledge of applicable Quality & Regulatory requirements and evolving trends and supporting the CDMO/CLO to meet these standards

Required qualifications and experience

  • A Bachelor or Master’s degree in a relevant discipline and 12+ years of GxP industry experience within biotechnology, pharmaceuticals, or life sciences
  • 5+ years of contractor’s quality management experience in a GxP regulated environment such as within biotechnology, pharmaceuticals, or life sciences
  • 4+ years of experience in a leadership role managing teams supporting GxP Operations
  • Strong comprehension of current pharmaceutical regulations and guidances (FDA/Health Canada/EU/ICH) and regulatory expectations for assigned function
  • Good ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures
  • A thorough understanding of drug substance development process and monoclonal antibody manufacturing processes and testing
  • Strong experience with various software/databases such as, but not limited to, ERP, MES, eQMS and LIMS
  • Excellent presentation skills with an ability to adjust to both technical and non-technical audiences 
  • Strong communication, teamwork and relationship building skills across the organization 
  • The ability to apply pragmatic, risk-based decision making
  • Strong ability to be strategic, yet hands-on and detail oriented

 

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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