Director, CMC Quality

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

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

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.

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.