Development Scientist: External Analytics & QC

Alexion Pharmaceuticals, Inc.; New Haven (CT); On-site; USD 112,000 - 168,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. seeks a Development Scientist II to provide end-to-end scientific and operational oversight of GMP analytical activities conducted by external laboratories for biologic drug substance and drug product programs.

You will collaborate with contract labs and internal partners to manage testing, investigate results, review data, and deliver documentation to support release, stability, regulatory submissions, and lifecycle activities.

Qualifications

• Ph.D. 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.
• Demonstrated experience supporting Good Manufacturing Practice analytical testing for biologic drug substance, drug product, or other complex pharmaceutical products.
• Experience leading or supporting laboratory investigations involving Out-of-Specification, Out-of-Trend, atypical, invalid, or unexpected analytical results, including root‑cause analysis, impact assessment, result disposition, and corrective or preventive action development.
• Demonstrated strong mental acuity, high attention to detail, ability to evaluate analytical data, recognize unexpected assay behavior, develop scientifically justified investigation plans, and communicate conclusions through clear technical documentation.
• Working knowledge of current Good Manufacturing Practice requirements and applicable FDA, ICH, USP, and EP expectations.
• Experience managing multiple analytical activities, investigations, and documentation deliverables concurrently while maintaining quality and meeting time‑sensitive program commitments.
• Effective scientific writing, presentation, and communication skills, with the ability to lead technical discussions involving external laboratories and cross‑functional stakeholders. Proficiency with MS Word, Excel, PowerPoint, Outlook, Teams, and collaborative document‑management tools is required.
• The duties of this role are generally conducted in an office and laboratory environment. Candidates must have the ability to bend, reach and stand, with lifting up to 15 pounds and carry over short distances.
• Ability to travel up to 10%, if needed.

Responsibilities

• Provide scientific and operational oversight of external analytical laboratories performing release, stability, characterization, verification, validation, and investigational testing for biologic drug substance and drug product programs.
• Leading laboratory investigations from initiation through closure, including Out-of-Specification, Out-of-Trend, and atypical analytical results. You will develop scientifically justified investigation strategies, evaluate potential root causes, assess product impact, and support corrective actions.
• Serving as a primary technical liaison with contract laboratories, translating internal program requirements into clear testing requests, deliverables, timelines, and documentation expectations while resolving scientific, quality, and operational issues that could affect critical program milestones.
• Reviewing analytical data and technical documentation, including protocols, raw data, investigation reports, method verification and validation reports, stability data, Certificates of Analysis, and other records needed to support material disposition and regulatory commitments.
• Coordinating external testing activities across multiple programs, proactively tracking testing status, laboratory investigations, analytic reports, sample requirements, documentation, and critical‑path deliverables. You will communicate risks early and establish practical plans to keep work moving.
• Partnering with Quality Assurance, Stability, Manufacturing, Analytical Development, Regulatory, and program teams to align investigation strategies, evaluate analytical risks, resolve documentation gaps, and ensure timely delivery of compliant analytical data.
• Driving continuous improvement of external laboratory oversight, including development of investigation checklists, templates, tracking tools, performance measures, and standardized ways of working that improve investigation quality, documentation consistency, and cycle time.
• Supporting audit, inspection, and regulatory readiness by ensuring that external analytical records are complete, traceable, scientifically defensible, and readily available for health authority requests, internal audits, and regulatory submissions.

Skills

Analytical thinking

Technical writing

Cross-functional collaboration

Communication

Education

Ph.D. in Biochemistry or related discipline

M.S. in Biochemistry or related discipline

Tools

Veeva Vault Quality

LIMS

ValGenesis

Kneat

MS Word

MS Excel

MS PowerPoint

MS Outlook

MS Teams

Job description

Alexion Pharmaceuticals, Inc. seeks a Development Scientist II to provide end-to-end scientific and operational oversight of GMP analytical activities conducted by external laboratories for biologic drug substance and drug product programs.

You will collaborate with contract labs and internal partners to manage testing, investigate results, review data, and deliver documentation to support release, stability, regulatory submissions, and lifecycle activities.