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

Alexion Pharmaceuticals, Inc.; New Haven (CT); On-site; USD 95,000 - 140,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. is seeking a Development Scientist II to join the External Analytical Development and Quality Control group in New Haven.

This role drives high-quality, compliant external QC testing with ownership of laboratory investigations through external contract laboratories and change controls related to ADQC biologic programs. You will partner with QA, Compliance, Analytical Development and Stability teams to ensure timely LIR closures and generation of final release CoAs

Qualifications

• Experience leading lab investigations (LIRs) and CAPAs in pharma or biotech.
• Strong accuracy in documentation and data review.
• Knowledge of cGMP, FDA regulations, ICH guidelines and EU regulations.

Responsibilities

• Generate and own LIRs for OOS, OOT, and atypical results with root-cause analysis and CAPAs.
• Design investigational testing plans for compliant closure of investigations.
• Lead cross-functional meetings with QA to align investigations.
• Create plans, track, and present timelines to meet targets.
• Review analytical data to ensure assay performance.
• Identify opportunities to improve systems for cGMP compliance.
• Demonstrate strong presentation skills.

Skills

Analytical thinking

Problem solving

Documentation accuracy

Cross-functional collaboration

MS Word

MS Excel

MS PowerPoint

cGMP knowledge

Regulatory compliance

Communication skills

Education

Advanced degree in Biochemistry, Chemistry or related

Tools

Veeva Vault

LIMS

ValGenesis

Kneat

JMP

Tableau

SAS

Job description

This Is What You Will Do

This Development Scientist II will be a key team member in Alexion’s External Analytical Development and Quality Control group. This position is responsible for maintaining the highest standard of quality and compliance of external quality control testing (GMP) laboratories. This candidate will be responsible for initiation and ownership of laboratory investigations (LIRs) through strong liaison with external contract laboratories and change controls relevant to ADQC biologic programs. The candidate will ensure timely, compliant, and high-quality delivery for LIR closure to enable the generation of final release CoAs. The role will work closely with internal Quality Assurance, Compliance, Analytical Development and Stability teams to ensure product to patients.

You Will Be Responsible For

• Responsible for generating and/or mirroring, reviewing, providing assessments, and driving 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.
• Strong presentation skills

You Will Need To Have

• A successful candidate will have strong mentalacuity with high attention to detail and ability tomaintainaccuracy in documentation and processes.
• Excellent analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.
• A broad knowledge of Pharmaceutical Quality Assurance, regulatorycompliance,and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Strongproficiencyin quality management systems and effective communication skills for interacting with cross-functional teams.
• Strong proficiency with MS Word, Excel, PowerPoint.
• Ability tobend, reach and stand,withliftingto15poundsand carrying over short distances.
• Ability to travel up to 10%, if needed.
• Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry or related discipline with 2-5 years (Ph.D.) or 10+ (M.S.) hands on biological analytical development experience in pharmaceutical industry.

We Would Prefer You To Have

• Working knowledge in validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, Kneat, etc.
• Knowledge of pharmaceutical/biotechnology manufacturing process
• 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

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.