Development Scientist II, Analytical Development and Clinical QC (ADQC)

AstraZeneca
Connecticut
Full timeFunction: Research & Scientific (R&D)Experience: 2-10 yearsSkills: ["Attention to detail","Accurate documentation","Analytical and problem-solving","Risk assessment","Root cause analysis"]

Serve as a key member of External Analytical Development and Quality Control, ensuring high standards of GMP-compliant quality for external quality control testing in support of biologic programs. Own laboratory investigations to close OOS/OOT/atypical results using root cause analysis and CAPAs, design compliant investigation plans, and review analytical data for assay performance. Partner with QA, Compliance, Analytical Development, and Stability teams to deliver timely, compliant LIR closures enabling final release CoAs.

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AstraZeneca
AstraZeneca
2 days ago

Development Scientist II, Analytical Development and Clinical QC (ADQC)

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Last checked: 12 hours agoStatus: Live

Job Summary

Serve as a key member of External Analytical Development and Quality Control, ensuring high standards of GMP-compliant quality for external quality control testing in support of biologic programs. Own laboratory investigations to close OOS/OOT/atypical results using root cause analysis and CAPAs, design compliant investigation plans, and review analytical data for assay performance. Partner with QA, Compliance, Analytical Development, and Stability teams to deliver timely, compliant LIR closures enabling final release CoAs.
Location: Connecticut
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •Maintain the highest quality and compliance standards for external quality control testing (GMP) laboratories supporting ADQC biologic programs.
  • •Initiate and own laboratory investigations (LIRs) in liaison with external contract laboratories and manage change controls relevant to ADQC programs.
  • •Generate, mirror, review, and drive closure of LIRs for OOS, OOT, and atypical results using structured root cause analysis, impact assessment, and/or CAPAs.
  • •Design investigational testing plans to ensure compliant closure within the quality system and create plans, track, and present timelines to meet targets.
  • •Perform review of analytical data to ensure expected assay performance and lead/facilitate cross-functional meetings with QA for investigation alignment.
Travel: Low travel

Key Requirements

  • •Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry or related discipline, with 2–5 years (Ph.D.) or 10+ years (M.S.) hands-on biological analytical development experience in the pharmaceutical industry.
  • •Strong analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.
  • •Broad knowledge of pharmaceutical quality assurance, regulatory compliance, and/or quality control, including cGMP, FDA regulations, and familiarity with ICH and EU regulations.
  • •Strong proficiency in quality management systems and effective communication with cross-functional teams.
  • •Strong proficiency with MS Word, Excel, and PowerPoint, with attention to detail and accuracy in documentation and processes.
Experience:2-10 yearsPharmaceutical industryBiological analytical developmentGMPFDAICHEU regulations
Education:
Skills:Attention to detailAccurate documentationAnalytical and problem-solvingRisk assessmentRoot cause analysis
Tech Stack:MS WordExcelPowerPointVeeva Vault (EQV)LIMSValGenesisKneatJMPTableauSASMicrosoft SharePointSharePointMicrosoft BoxBOX

Company Brief

AstraZeneca
Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Cambridge, United Kingdom
Founded: 1999
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn