{"id":3120236,"url":"https://alion.io/job/abcellera-director-cmc-quality","title":"Director, CMC Quality","company":{"id":179322,"name":"AbCellera","domain":"abcellera.com","url":"https://alion.io/company/abcellera","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Vancouver, Canada"],"countries":["CA"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":180000,"max":220000,"currency":"CAD","period":"year","gross":null,"usd_annual":156922},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-22T23:39:32Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-24T15:10:53Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"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.\nWe 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. \nHow you might spend your days \nServing as the senior Quality leader on the CMC core team to communicate product Quality strategy, deliverables, risks, and changes\nLeading the CMC product Quality sub-team to define product quality strategy, priorities, and deliverables throughout the product lifecycle\nExecuting product strategy using strong quality and scientific knowledge, aligned with CMC development, technology transfers, and global regulatory filing strategies\nWorking 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\nMaintaining the Product Quality Risk Register to identify, mitigate, and escalate issues related to manufacturing, analytical methods, or supply chain\nMonitoring and reviewing cross-functional processes and product data to identify trends and ensure quality and compliance risks are proactively addressed and escalated, as needed\nInterpreting 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\nAssessing changes, deviations, and other events for product quality impact and ensure appropriate implementation plans are developed\nProviding 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\nWe’d love to hear from you if\nYou 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 \nYou have a deep understanding of global cGMP regulations (Health Canada FDA, EMA, ICH) including phase-appropriate requirements for clinical vs. commercial products\nYou have demonstrated expertise in designing and executing product & process control and comparability strategies\nYou 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\nYou have demonstrated strong leadership capability with ability to align on, make and act on decisions while balancing speed, quality, and risk\nYou are a detailed-oriented individual, highly organized, and thrive in collaborative and cross-functional fast-paced environments while managing multiple priorities\nWhat we offer\nAbCellera’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. \nYou 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.\nAbout AbCellera\nCreating medicines is the most important work we can do. \nWe 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.\nToday, 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.\nWe 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. \nWe 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.\nTo apply\nPlease 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.","description_format":"text","description_chars":5958,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Drug Discovery","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-10-23T00:10:02Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":42,"reasons":["conf:3","win:early"],"computed_at":"2026-10-24T06:02:35Z"},"pay":{"stated_usd_annual":156922,"is_top_pay":false},"html_url":"https://alion.io/job/abcellera-director-cmc-quality","json_url":"https://alion.io/job/abcellera-director-cmc-quality.json","meta":{"generated_at":"2026-10-24T17:19:36Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":25129,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":179322},"rest":"https://alion.io/mcp/rest/get_company?id=179322"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabcellera-director-cmc-quality"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fabcellera-director-cmc-quality"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fabcellera-director-cmc-quality"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/abcellera-director-cmc-quality\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabcellera-director-cmc-quality"}]}