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

Alexion•New Haven, CT

About The Position

The Development Scientist II will provide end-to-end scientific and operational oversight of Good Manufacturing Practice analytical activities performed by external laboratories for biologic drug substance and drug product programs. As part of the External Analytical Development and Quality Control team, the role manages analytical testing, investigates unexpected results, evaluates scientific data, and delivers documentation supporting batch release, stability programs, regulatory submissions, and product lifecycle activities. The position works directly with contract laboratories and internal partners across a global external laboratory network and leads complex analytical investigations and improvements to external testing systems. The role oversees external laboratory testing and investigations, reviews analytical data and technical records, coordinates activities across programs, and partners with Quality Assurance, Stability, Manufacturing, Analytical Development, Regulatory, and program teams. It also supports audit, inspection, and regulatory readiness by ensuring that external analytical records are complete, traceable, scientifically defensible, and available when needed. Duties are generally conducted in an office and laboratory environment. Travel may be required up to 10%.

Requirements

Advanced Ph.D. degree in Biochemistry, Chemistry, or a related discipline, with 2–5 years of hands-on biological analytical development experience in the pharmaceutical industry; alternatively, an M.S. with 10+ years of such experience.
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.
Strong analytical judgment and attention to detail, including the 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 United States Food and Drug Administration, International Council for Harmonisation, United States Pharmacopeia, and European Pharmacopoeia 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, including the ability to lead technical discussions with external laboratories and cross-functional stakeholders.
Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, Teams, and collaborative document-management tools.
Ability to bend, reach, and stand, and to lift up to 15 pounds and carry items over short distances.

Nice To Haves

Experience providing technical oversight of testing performed by external contract laboratories or contract development and manufacturing organizations.
Experience with analytical methods used to evaluate biologic products, such as chromatography, electrophoresis, potency or binding assays, particulate testing, compendial testing, and microbiological methods.
Experience generating, reviewing, or approving Certificates of Analysis and analytical documentation supporting batch release and stability programs.
Experience with electronic quality and document-management systems such as Veeva Vault Quality, Laboratory Information Management Systems, ValGenesis, Kneat, or comparable validated platforms.
Experience supporting analytical method transfer, method verification, method validation, stability testing, process performance qualification, or clinical-to-commercial program transitions.
Experience preparing analytical data packages or technical documentation for regulatory submissions, health authority responses, audits, or inspections.
Experience using data-analysis and visualization tools such as JMP, Tableau, or comparable statistical software.
Experience improving laboratory investigation processes, external laboratory governance, analytical tracking systems, or standardized technical workflows.

Responsibilities

Provide scientific and operational oversight of external laboratories performing release, stability, characterization, verification, validation, and investigational testing for biologic drug substance and drug product programs.
Lead laboratory investigations from initiation through closure, including Out-of-Specification, Out-of-Trend, and atypical analytical results; develop investigation strategies, evaluate potential root causes and product impact, and support corrective and preventive actions.
Serve as a primary technical liaison with contract laboratories, communicating program requirements, testing requests, deliverables, timelines, and documentation expectations and resolving scientific, quality, and operational issues.
Review analytical data and technical documentation, including protocols, raw data, investigation reports, method verification and validation reports, stability data, Certificates of Analysis, and records supporting material disposition and regulatory commitments.
Coordinate external testing across multiple programs by tracking testing status, investigations, reports, sample requirements, documentation, and critical-path deliverables; communicate risks and establish plans to keep work moving.
Partner 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.
Improve external laboratory oversight by developing investigation checklists, templates, tracking tools, performance measures, and standardized practices that improve investigation quality, documentation consistency, and cycle time.
Support audit, inspection, and regulatory readiness by ensuring external analytical records are complete, traceable, scientifically defensible, and readily available for health authority requests, internal audits, and regulatory submissions.