Principal Scientist, Protein Characterization

We are seeking an innovative Principal Scientist to join the Protein Characterization group within Analytical Development & Quality Control (ADQC) at Alexion, AstraZeneca Rare Disease. This is an on-site role based in New Haven, CT.

The successful candidate will be a scientific and technical leader. They will deliver proficiency in liquid chromatography method development, fractionation, and characterization of charge, size, and other product-related variants for biologics. This role plays a critical part in supporting biologics development throughout both clinical trials and market launch phases, including CQA assessment, forced degradation studies, and comparability evaluations.

You will be responsible for:

• Serve as a technical subject matter expert (SME) in LC-based protein variant characterization, including method development, optimization, fractionation, and troubleshooting!
• Lead and implement fractionation studies to isolate and characterize product-related variants.
• Build, develop, and apply methods for charge variant (e.g., IEX, icIEF), size variant (e.g., SEC, CE-SDS), or other product-related variant characterization of biologics.
• Support and/or lead forced degradation studies to assess product stability and degradation pathways.
• Perform and interpret data for critical quality attribute (CQA) assessment and risk evaluation.
• In depth understanding of product comparability assessment supporting process changes at clinical and commercial stages.
• Author, review, and approve technical documentation, including development reports related to protein forced degradation, fractionation, comparability, and CQA, as well as regulatory submissions (IND, BLA, MAA).
• Mentor and provide scientific guidance to junior scientists, contributing to team capability building and technical excellence.
• Partner cross-functionally with Process Development, CMC, Regulatory, Quality, and Manufacturing teams to ensure robust analytical strategies aligned with project and regulatory expectations.
• Represent ADQC in internal governance forums and external interactions, as appropriate.

You will need to have:

• BS with 12 years of experience, MS with 10 years of relevant industry experience, or PhD with a of 6 years of relevant industry experience
• Deep expertise in developing and applying methods related to liquid phase chromatography for biologics.
• Strong experience with charge and size variant or other product-related variant characterization.
• Proven experience with fractionation techniques to support structural and functional characterization.
• Solid understanding of protein degradation pathways and analytical approaches for forced degradation.
• Experience supporting CQA assessment and comparability studies.
• Familiarity with cGMP expectations, data integrity, and regulatory requirements for analytical development.
• Strong data interpretation, problem-solving, and scientific interpersonal skills.
• The duty of this role involves lab-based work. Employees must be able, with or without accommodation, to lift/carry 15/30 pounds unassisted/assisted.

We would prefer you to have:

• Extensive hands-on experience in protein characterization for biologics within a pharmaceutical or biotechnology environment.
• Experience supporting late-stage development and/or commercial products.
• Prior involvement in regulatory submissions or health authority interactions.
• Demonstrated leadership in cross-functional analytical strategy development.

When we put unexpected teams in the same room, we spark bold thinking with the power to inspire 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 three 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 unique 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 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.