Director, CMC Quality

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients who need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We are looking for an experienced Director, CMC Quality to serve as a technical quality expert for antibody products during clinical development all the way through post-commercialization. As a core member of the CMC team, you will provide quality leadership and serve as the single point of contact representing all quality functions for technical decisions, risks, and activities associated with the assigned products. This role requires deep technical and compliance expertise, strategic thinking, and cross-functional collaboration to ensure product quality, regulatory compliance, and lifecycle continuity are met and maintained. You’ll work closely with the Product and Analytical Development teams, Quality, Manufacturing, Supply Chain, Clinical and Regulatory teams, ultimately shaping how our antibody therapies reach patients.  How you might spend your days  Serving as the senior Quality leader on the CMC core team to communicate product Quality strategy, deliverables, risks, and changes Leading the CMC product Quality sub-team to define product quality strategy, priorities, and deliverables throughout the product lifecycle Executing product strategy using strong quality and scientific knowledge, aligned with CMC development, technology transfers, and global regulatory filing strategies Working cross-functionally to implement phase-appropriate control strategies, including starting materials, drug substance and drug product specifications, in-process controls, stability strategy, and product comparability strategies Maintaining the Product Quality Risk Register  to identify, mitigate, and escalate issues related to manufacturing, analytical methods, or supply chain Monitoring and reviewing cross-functional processes and product data to identify trends and ensure quality and compliance risks are proactively addressed and escalated, as needed Interpreting and applying applicable regulatory guidelines and directives (e.g. 21CFR, EU GMP, USP,  Ph. Eur., and ICH) to product quality, staying abreast of changes and advising stakeholders appropriately Assessing changes, deviations, and other events for product quality impact and ensure appropriate implementation plans are developed Providing subject matter Quality expertise into the preparation and review of clinical and commercial regulatory submissions (e.g. IND/CTA/BLA/MAA), product-related responses to health authority questions, and during health authority inspections We’d love to hear from you if You have a Bachelor’s degree in Life Sciences or Engineering (e.g., Biology, Biochemistry, Chemical Engineering), with an MS or PhD preferred, and 12+ years of biopharmaceutical experience in Quality, Regulatory, or Manufacturing Compliance, including CMC development and commercialization of products such as pre-filled syringes and autoinjectors; prior CMC Quality leadership experience is strongly preferred   You have a deep understanding of global cGMP regulations (Health Canada FDA, EMA, ICH) including phase-appropriate requirements for clinical vs. commercial products You have demonstrated expertise in designing and executing product & process control and comparability strategies You have excellent interpersonal and communications skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization You have demonstrated strong leadership capability with ability to align on, make and act on decisions while balancing speed, quality, and risk You are a detailed-oriented individual, highly organized, and thrive in collaborative and cross-functional fast-paced environments while managing multiple priorities What we offer AbCellera’s hiring range for this role is CAD $180,000 - $220,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, an annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution.  You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship are a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials. About AbCellera Creating medicines is the most important work we can do.  We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications. We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience.  We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. To apply Please submit your application through our website and refer to Job ID 23421 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.