Development Scientist I: Analytical Method Dev & QC

AstraZeneca plc

New Haven (CT)

Sur place

USD 90 000 - 120 000

Plein temps

Il y a 6 jours
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Résumé du poste

AstraZeneca plc in Connecticut seeks a Development Scientist I to advance analytical methods for biotherapeutics, focusing on icIEF and CE-based techniques. You will develop, qualify, and transfer methods while coordinating with R&D and QA/QC teams to support regulatory submissions.

The role involves supervising instrument operation, evaluating new technologies, and collaborating across laboratory functions to ensure robust, compliant analyses of therapeutic proteins.

Qualifications

  • Ph.D. with 0–2 years or master’s with 4–6 years or bachelor’s with 10+ years of related experience.
  • Analytical method development experience for protein/peptide analysis by gel/capillary electrophoresis in pharma/biotech is a plus.
  • Knowledge of protein characterization for therapeutics including monoclonal antibodies and glycoproteins.
  • Experience with assay development, qualification, and validation for protein therapeutics is a significant plus.
  • Ability to travel up to 20% for on-site training and troubleshooting.

Responsabilités

  • Develop, optimize, and qualify capillary electrophoresis methods to evaluate quality attributes of therapeutic proteins.
  • Organize activities and supervise operation and troubleshooting of analytical instruments (LabChip, iCE3, MauriCE, ProteoAnalyzer).
  • Support new technologies to improve throughput and cGMP testing.
  • Design and optimize workflows compliant with ICH Q14; author SOPs and development reports.
  • Work with R&D and QA/QC teams to transfer methods for development and clinical support.
  • Collaborate with Analytical Transfer Services to develop validation protocols and training.

Connaissances

Analytical method development
Problem solving
Analytical thinking
Communication
Travel up to 20%

Formation

Ph.D. in Chemistry/Biochemistry/Chemical Engineering
Master’s in Chemistry/Biochemistry/Chemical Engineering
Bachelor’s in Chemistry/Biochemistry/Chemical Engineering

Outils

Revvity LabChip
Protein Simple iCE3
MauriCE
ProteoAnalyzer

Description du poste

AstraZeneca plc in Connecticut seeks a Development Scientist I to advance analytical methods for biotherapeutics, focusing on icIEF and CE-based techniques. You will develop, qualify, and transfer methods while coordinating with R&D and QA/QC teams to support regulatory submissions.

The role involves supervising instrument operation, evaluating new technologies, and collaborating across laboratory functions to ensure robust, compliant analyses of therapeutic proteins.

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