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

This is what you will do:

ThisDevelopment Scientist IIwill be a key team member in Alexion’sExternalAnalyticalDevelopment and Quality Control group.This positionisresponsible formaintainingthe highest standard of quality and complianceofexternalquality controltesting(GMP) laboratories.This candidate willbe responsible forinitiation and ownership oflaboratory investigations (LIRs)throughstrong liaisonwithexternal contract laboratoriesandchange controls relevant to ADQC biologic programs. The candidate willensuretimely, compliant, and high-quality deliveryfor LIR closure toenable thegeneration of finalreleaseCoAs. The role willwork closely withinternal QualityAssurance, Compliance, Analytical Development andStabilityteamsto ensure product to patients.

You willbe responsible for:

• Responsible for generatingand/or mirroring, reviewing, providingassessments,and driving ownership ofLIRs to close outOut-of-Specification (OOS), Out-of-Trend (OOT), and atypical resultswithstructured root cause analysis, impactassessment,and/orcorrective/preventive actions (CAPAs).

• Designinvestigationaltestingplans ensuring compliant closure of all testing related investigations within the quality system.

• Leadand/orfacilitatecross-functional meetings with quality assurance to ensure structured investigation alignment.

• Create plans,track,and present timelines to meet established targets,goals,andobjectives.

• Perform review of analytical data to ensure expected assay performance. 

• Identifyopportunities for improvement in systems and make recommendations for effective changes to ensure compliance withcGMP.

• Strong presentation skills

You will need to have:

• A successful candidate will havestrongmental acuitywith 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. 

• A 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.

• Strongproficiencywith MSWord,Excel,PowerPoint. 

• Ability to bend, reach and stand, withlifting to 15 pounds andcarryingover short distances.

• Ability to travel up to 10%, if needed.

• Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry or related discipline with2-5years (Ph.D.) or10+ (M.S.) hands on biological analytical development experience inpharmaceuticalindustry.

We wouldpreferyou 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)withproficiencyin MicrosoftSharePointand/or BOX.