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 -…