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Quality Operations Manager - Drug Substance

AbCellera Biologics

AbCellera Biologics

Operations, Quality Assurance
Vancouver, BC, Canada
Posted on Thursday, December 21, 2023

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. AbCellera provides innovative biotech and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.

As a Specialist, QA Operations, you will be responsible for ensuring clinical batches are manufactured in compliance with current Good Manufacturing Practices (cGMP). You will play a key role in ensuring compliance with industry standards, regulations and facilitating efficient communication within our organization.You will be responsible to author, review and maintain documentation related to drug manufacturing as per Good Documentation Practices (GDP). This role entails a high level of collaboration and communication with other stakeholders in business such as but not limited to Manufacturing, Supply Chain, MSAT, Facilities & Engineering, Project Management Group and other Quality Functions.

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 would 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 new programs and capabilities that accomplish important goals.
  • You have a bias towards continuous improvement of existing processes.
  • You are enthusiastic about applying your expertise in quality assurance.
  • You are an outstanding communicator and teammate.

How you might spend your days

  • Providing quality oversight and line clearance support on the cleanroom floor for manufacturing operations of Drug Substance (DS) and/or Drug Product (DP)
  • Developing and implementing quality procedures and systems to provide proper oversight of manufacturing activities such as product changeovers/ line clearance, batch record review, manufacturing floor oversight program, etc
  • Reviewing and supporting the implementation/revision of manufacturing procedures/documentation, such as, but not limited to batch records, gowning, cleaning, material and personnel flow, equipment operational procedures etc
  • Reviewing GMP documents and raw data, including executed batch records in paper and/or electronic forms, for compliance with applicable procedures and standards (incl. Data Integrity) to to support the disposition of clinical batches
  • Reviewing Quality events such as Deviations /Investigations (incl. Product Complaints), CAPAs, and Change controls. Participate in cross-functional teams to drive investigation closeouts, determine root cause, and implement appropriate Corrective and Preventive Action
  • Participating in risk assessments related to manufacturing operations including risk evaluation, mitigation, documentation and reporting
  • Reviewing all required engineering documentation in support of design, build and start-up of new clinical manufacturing facility. Perform ongoing QA review of required F&E documentation
  • Reviewing material qualification related documentation to support procurement and usage of GMP materials
  • Maintaining close collaboration with other Quality departments, such as Quality Control, Quality Systems, Supplier Quality, QA Validation, Warehouse QA, Digital Quality and QA for QC and other stakeholders in business such as Manufacturing, MSAT, Supply Chain, F&E and project management group
  • Maintaining current knowledge of applicable Quality & Regulatory requirements and evolving trend
  • Maintaining inspection readiness of the facility. Identify and escalate risks to members of the site leadership team. Supporting inspections and audits of the clinical manufacturing facility

Required qualifications and experience.

  • BSc or MSc in a relevant scientific discipline and 8+ years of industry experience working with Good Documentation Practices (GDP) in a pharmaceutical or biotechnology company.
  • Experience in manufacturing of biologically derived drug products (DS (USP/ DSP), DP/FDP) in quality or manufacturing roles is preferable
  • Experience in ensuring timely review of procedures, batch documentation, logbooks, deviations, CAPAs and change controls
  • Excellent written and verbal communication skills, with the ability to convey complex technical information, clearly and concisely
  • Proficiency in electronic document management systems and software tools
  • Strong attention to detail and organizational skills
  • Sound working knowledge of cGMP, Health Canada, EMA, FDA, USP and EP guidelines
  • Strong interpersonal skills with the ability to work collaboratively as a member of a cross-functional team

What we offer

AbCellera’s hiring range for this role is $94,000 - $118,000 CAD 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.

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 will 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 are a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This is not 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 are looking for someone like you to support and organize our efforts along the way.