Development Scientist II, Analytical QC & Investigations

AstraZeneca; New Haven (CT); On-site; USD 95,000 - 125,000; Full time

Job summary

AstraZeneca, in its External Analytical Development and Quality Control group, seeks a Development Scientist II to maintain high quality in external QC testing and lead laboratory investigations with external labs. You will drive timely LIR closures and coordinate with QA, Analytical Development, and Stability teams to ensure compliant release of CoAs.

Ideal candidates possess advanced degrees in Biochemistry or Chemistry with substantial hands-on experience in pharmaceutical analytics and

Qualifications

• Advanced degree in Biochemistry, Chemistry or related discipline
• 2–5 years (Ph.D.) or 10+ years (M.S.) hands-on biological analytical development experience

Responsibilities

• Generate and own LIRs to close OOS/OOT with root cause analysis and CAPAs
• Design investigational testing plans for compliant closure
• Lead cross-functional meetings with quality assurance for investigation alignment
• Create plans, track timelines and present targets
• Review analytical data to ensure assay performance
• Identify opportunities for system improvements to ensure cGMP compliance
• Demonstrate strong presentation skills

Skills

Analytical thinking

Problem-solving

Cross-functional collaboration

MS Office

Communication skills

Travel up to 10%

Education

MS in Biochemistry/Chemistry

PhD in Biochemistry/Chemistry

Tools

Veeva Vault (EQV)

LIMS

Val Genesis

Kneat

Job description

AstraZeneca, in its External Analytical Development and Quality Control group, seeks a Development Scientist II to maintain high quality in external QC testing and lead laboratory investigations with external labs. You will drive timely LIR closures and coordinate with QA, Analytical Development, and Stability teams to ensure compliant release of CoAs.

Ideal candidates possess advanced degrees in Biochemistry or Chemistry with substantial hands-on experience in pharmaceutical analytics and