Associate Director, Analytical Development and Clinical QC

This position will play a key leadership role in Alexions Late Stage Analytical team which requires analytical expertise and proven success in management of development projects through the CMC lifecycle. This position will lead multiple projects in parallel and working closely with other PDCS teams Regulatory QA and external QC laboratories as a lead to designing the strategy of late-stage analytical activities including method transfer/validation compendia method verification and overall testing strategy throughout all phases of the product lifecycle. Moreover this position will lead to authoring regulatory filing in relevant analytical sections with a focused understanding of country-specific requirements!

You will be responsible for:

• Leading all aspects of analytical method validation transfers and compendia method verifications across all stages of clinical development and method life-cycle stages
• Analytical lead for CMC programs emphasizing late-stage programs which may be internal or external with cross functional collaboration.
• Analytical end-to-end strategy for key late-stage biologics programs including analytical control strategy method lifecycle and QC testing supervision problem resolution and inquiries and key BLA/commercial analytical
• Supervision of analytical QC testing problem-solving and data analysis are conducted for the CMC program. This provides oversight of the analytical programs health. It also helps identify potential analytical and program risks early.
• Leading independently regulatory authoring for both medical and market-facing submissions for all markets including responses to health authority queries and requests for information

You will need to have:

• Advanced degree (PhD or MSc) in Biochemistry Analytical Chemistry Molecular Biology Pharmaceutical Sciences or related field with 812 years of progressive experience in biologics analytical development across clinical and commercial stages
• Validated first-hand expert knowledge and technical proficiency with monoclonal antibodies bispecifics fusion proteins.
• Technical expertise in chromatography (e.g. SEC RP IEX) capillary electrophoresis (CE-SDS cIEF) spectroscopy (UV/Vis fluorescence CD) bioassays (binding potency) and residuals/impurities testing (HCP DNA residual Protein A)
• Compendia method experience emphasizing USP EP and JP compliance
• Strong written and verbal skills for clear reports regulatory submissions and presentations to technical and non-technical collaborators
• Demonstrated success in method development qualification/validation (per ICH Q2) transfer to QC/CMOs and continued verification for commercial control strategies.
• Strong command of ICH (Q5E Q6B Q8Q12) USP/EP FDA/EMA expectations for biologics GMP/GLP compliance and authoring/reviewing CTD Module 3 IND/IMPD BLA/MAA analytical sections and responses to agency queries.
• Proficiency with GxP compliant documentation ALCOA data integrity principles OOS/OOT handling deviation/CAPA management and audit readiness
• Ability to define critical quality attributes (CQAs) build specifications and implement control approaches aligned with Quality by Build (QbB)

We would prefer you to have:

• 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. Thats why we work on average a minimum of four days per week from the office. But that doesnt mean were 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.

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.