Development Scientist II, Analytical Development and Quality Control
AstraZeneca GmbH, New Haven, CT, United States
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.
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.
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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.
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.
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