Principal Scientist, Protein Characterization
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
