Development Scientist II, Analytical Development...

About the role

This Development Scientist II will be a key team member in Alexion's External Analytical Development and Quality Control group, responsible for maintaining the highest standard of quality and compliance of external quality control testing (GMP) laboratories.

The candidate will ensure timely, compliant, and high-quality delivery for laboratory investigation report (LIR) closure to enable the generation of final release Certificates of Analysis (CoAs). The role will work closely with internal Quality Assurance, Compliance, Analytical Development, and Stability teams to ensure product delivery to patients.

Responsibilities

• Generate, mirror, review, assess, and drive ownership of LIRs to close out Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical results with structured root cause analysis, impact assessment, and/or corrective/preventive actions (CAPAs).
• Design investigational testing plans ensuring compliant closure of all testing-related investigations within the quality system.
• Lead and/or facilitate cross-functional meetings with Quality Assurance to ensure structured investigation alignment.
• Create plans, track, and present timelines to meet established targets, goals, and objectives.
• Perform review of analytical data to ensure expected assay performance.
• Identify opportunities for improvement in systems and make recommendations for effective changes to ensure compliance with cGMP.
• Demonstrate strong presentation skills.

Requirements

• Strong mental acuity with high attention to detail and ability to maintain accuracy in documentation and processes.
• Excellent 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 inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulations.
• Strong proficiency in quality management systems and effective communication skills for interacting with cross-functional teams.
• Proficiency with MS Word, Excel, and PowerPoint.
• Ability to bend, reach, and stand, with lifting up to 15 pounds and carrying over short distances.
• Ability to travel up to 10%, if needed.

Qualifications

Advanced degree (M.S. or Ph.D.) in Biochemistry, Chemistry, or a related discipline with:

• 2–5 years (Ph.D.) or 10+ years (M.S.) of hands-on biological analytical development experience in the pharmaceutical industry.

Skills

• Working knowledge of validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, Kneat, etc.
• Knowledge of pharmaceutical/biotechnology manufacturing processes.
• Database management/statistical analysis (e.g., JMP, Tableau, SAS) with proficiency in Microsoft SharePoint and/or BOX.

Date posted: 09-Aug-2026 | Closing date: 03-Sep-2026