Development Scientist II, Analytical Development and Quality Control · Analytical Sciences

Sat, 25 Apr 2026 14:08:33 GMT
Engineering

Analytical Sciences · New Haven, Connecticut, United States of America · hybrid

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 direction,pinpointing 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 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 you will join curious minds who pair groundbreaking science with data and digital tools to push beyond the expected. We bring together diverse perspectives,from internal teams to partners in academia and biotech,to 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 tomorrow's medicines with us today!