Development Scientist II, Analytical Development and Quality Control

Are you ready to turn deep protein characterization into decisions that shape the quality safety and success of biologics reaching patients Do you thrive on translating complex charge and size variant data into clear strategies that stand up to regulatory scrutiny and accelerate development In this role you will lead analytical characterization from clinical through commercial stages strengthening the scientific backbone of our biologics programs. You will design and optimize high-impact methods drive comparability and forced degradation studies and author CMC sections that guide regulatory filings. Working with cross-functional teams you will convert data into directionpinpointing critical quality attributes de-risking process changes and enabling faster better decisions for our pipeline.

Accountabilities:

• Protein Variant Enrichment and Characterization: Lead enrichment fractionation and characterization of protein size and charge variants to define and monitor critical quality attributes guiding process and formulation strategies.
• Analytical Method Development and Optimization: Conduct studies and develop/optimize robust HPLC/UPLC CE-SDS icIEF and related methods to characterize biotherapeutic molecules across development stages ensuring phase-appropriate transferable methods.
• Comparability and Stress Studies: Design and lead comparability and forced degradation programs to map degradation pathways assess product robustness and inform lifecycle decisions.
• Cross-Functional Leadership: Represent the Protein Characterization group on development teams driving scientific problem-solving and aligning analytical strategy with program goals and timelines.
• Regulatory and Documentation Excellence: Author CMC sections for regulatory filings technical reports protocols SOPs and work practices; ensure data integrity and clarity that accelerates regulatory interactions.
• Innovation and Technology Scouting: Evaluate emerging technologies and independently develop forward-looking protein characterization strategies that improve sensitivity throughput and insight.
• Project and People Leadership: Manage projects independently set priorities track commitments and mentor junior scientists to build capability and consistency in laboratory execution.

Essential Skills/Experience:

• BS degree with 10 years MS degree with 8 years or Ph.D. degree with 2 years in Chemist Biochemistry or related field of Industry experience
• Experienced in separations science (e.g. SEC RP IEX HIC CE-SDS and cIEF).
• experienced in protein size and charge variants identification and product quality attribute severity assessment.
• Planning and organizing skills to plan execute and track commitments of the laboratory and to adjust to changing priorities.
• High emotional intelligence excellent people skills and effective communication skills.

Desirable Skills/Experience:

• Experience in CMC development activities and previous experience as project lead for analytical function.

Experience in characterization of various biologic modalities (e.g. mAb multi-specifics fusion protein enzyme). When we put unexpected teams in the same room we ignite ambitious thinking with the power to inspire 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 three 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 unique and ambitious world.

Why AstraZeneca:

Here you will join curious minds who pair ground breaking science with data and digital tools to push beyond the expected.

We bring together diverse perspectivesfrom internal teams to partners in academia and biotechto solve hard problems faster often by putting unexpected teams in the same room to spark new ideas. Your analytical decisions will influence program direction speed development and ultimately help deliver medicines to people with serious conditions.

We value ambition and kindness in equal measure giving you the autonomy resources and collaborative environment to learn lead and make a meaningful measurable impact.

If you are ready to turn rigorous protein science into real-world impact step forward and shape the quality of tomorrows medicines with us today!

Date Posted

Closing Date

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.