Associate Director, Analytical Development and Clinical QC

Experience in microbiology assays (e.g., required day of harvest, bioburden, endotoxin, sterility, and CCIT)

Background in analytical method development and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as statistical data analysis and relevant tools

Experience leading all aspects of CDMO/CRO analytical activities including routine testing oversight, troubleshooting and investigations and method qualification, validation, and transfer.

Experience in country specific compendia requirements and knowledge of CHP

Experience leading ICH stability programs (Q1), shelf-life modeling, and projections and related statistical approaches.

Experience in extended characterization and comparability including forced degradation studies for process comparability.

Familiarity with LIMS, ELN, Chromatography Data Systems, data visualization, and automation/robotics in analytical workflows

Expertise with AI tools and statistical software, for example JMP

Track record of building, mentoring, and developing high-performing teams; resource planning, and performance management

The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees will work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

When we put unexpected teams in the same room, we ignite ambitious thinking with the power to encourage life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our outstanding and ambitious world.

Why AstraZeneca:

Here, courage, curiosity, and collaboration fuel a relentless focus on transforming cancer outcomes, powered by a pipeline that fuses cutting-edge science with advanced technology. You will work in an environment where unexpected teams come together to spark bold ideas, backed by meaningful investment and a clear path from discovery to impact. We value kindness alongside ambition, and we empower leaders at every level to ask sharp questions, take smart risks, and turn data into decisions that help patients sooner.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.