Scientist III, Analytical Development and Clinical QC

As a Scientist III in Analytical Development and Clinical QC at Alexion youll be at the forefront of our Late-Stage Analytical team! This pivotal role demands analytical expertise and a proven track record in managing analytical development projects throughout the CMC lifecycle. Youll prioritize multiple projects collaborating closely with PDCS teams Regulatory QA and external QC laboratories. Develop and implement late-stage analytical strategies including method transfer validation and verification while authoring regulatory filings with a keen understanding of country-specific requirements. As the analytical functional lead for clinical CMC programs youll drive end-to-end analytical activities from Phase 3 through commercialization.

Accountabilities

• Lead all aspects of analytical method validations transfers and compendia method verifications across all stages of clinical development and method life-cycle stages.
• Serve as the analytical lead for CMC programs focusing on late-stage programs with rigorous cross-functional collaboration.
• Develop and implement an analytical end-to-end strategy for key late-stage biologics programs including control strategy lifecycle management and QC testing oversight.
• Lead all aspects of analytical QC testing troubleshooting issues and conduct data analysis to ensure program health and identify potential risks.
• Author regulatory submissions for clinical and commercial markets addressing health authority queries and requests for information.

Essential Skills/Experience

• PhD in Biochemistry Analytical Chemistry Molecular Biology Pharmaceutical Sciences or related field with 6 years experience
• MSc in Biochemistry Analytical Chemistry Molecular Biology Pharmaceutical Sciences or related field with 10 years experience
• Proven hands-on strategic and technical expertise with monoclonal antibodies bispecific 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 with a focus on 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 commercial control strategies aligned with Quality by Design (QbD)
• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role employees must be able with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; 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.

Desirable Skills/Experience

• 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
• 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 in 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 and life cycle management.
• Digital laboratory systems and automation: 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

When we put unexpected teams in the same room we fuel ambitious thinking with the power to encourage life-changing -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.

At AstraZenecas Alexion division your work is more than just a job - its a mission to transform lives. Our dedication to patients drives everything we do. With a rapidly growing portfolio and entrepreneurial spirit akin to a leading biotech company youll thrive in an environment that develops innovation and growth. Here youll find an encouraging community of leaders and peers dedicated to making a difference for those living with rare diseases. Your career journey will be enriched by tailored development programs that align your growth with our mission.

Ready to make an impact Apply now to join our team!

Date Posted

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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.