Quality Control Analyst

Senior Quality Control AnalystAre you a scientific professional with expertise in analytical chemistry, biochemistry, formulation development, and pharmaceutical product development? We are seeking a Senior Scientist to provide technical leadership in analytical testing, formulation development, method development, and process optimization. This role supports the development and analysis of pharmaceutical, biotechnology, and related products while ensuring compliance with regulatory, quality, and operational requirements. The ideal candidate combines expertise in chemistry, biochemistry, analytical science, formulation development, method validation, laboratory operations, and project leadership with strong problem-solving and communication skills.Key ResponsibilitiesAnalytical Testing & Scientific AnalysisPerform advanced analytical testing utilizing a variety of laboratory techniques and instrumentation.Analyze materials, products, biological samples, and devices.Conduct complex scientific investigations and testing activities.Follow approved Standard Operating Procedures (SOPs) and analytical methods.Deliver accurate, high-quality scientific results.Method Development & ValidationDevelop, validate, optimize, and transfer analytical methods.Support routine and non-routine analytical testing requirements.Ensure analytical methods meet regulatory and quality standards.Maintain method documentation and technical records.Support technology transfer and laboratory implementation activities.Typical InstrumentationHPLC (High Performance Liquid Chromatography)GC (Gas Chromatography)LC-MSFTIRddPCR (Digital Droplet PCR)Other advanced analytical platformsFormulation DevelopmentDesign and develop robust formulations for:Small Molecule ProductsBiologicsEarly-Stage Clinical ProductsSupport formulation optimization activities.Evaluate formulation performance and stability.Recommend formulation improvements based on analytical findings.Contribute to product development programs.Process Development & Manufacturing SupportDevelop and optimize manufacturing processes for drug products.Support scale-up, process transfer, and production readiness activities.Interpret scientific and manufacturing data to drive process improvements.Collaborate with manufacturing teams to ensure successful process implementation.Support operational efficiency and product quality objectives.Data Analysis & Scientific InterpretationReview, analyze, and interpret scientific data.Identify trends, patterns, and potential issues.Draw scientifically sound conclusions from analytical results.Prepare recommendations and present findings to stakeholders.Support evidence-based decision-making.Technical LeadershipProvide work direction, coaching, and scientific guidance to laboratory personnel.Serve as a subject matter expert in chemistry, biochemistry, and formulation development.Support staff training on:Analytical TechniquesLaboratory ProceduresScientific InstrumentationSOP CompliancePromote technical excellence across the team.Client & Stakeholder SupportServe as a technical advisor to:ClientsProject TeamsLaboratory StaffManagementProvide scientific interpretation and recommendations.Present technical findings and project updates.Build strong collaborative relationships with internal and external stakeholders.Project ManagementParticipate in or lead scientific projects and programs.Support planning activities including:Project ObjectivesTimelinesResource RequirementsBudgetsPersonnel AllocationTrack project progress and communicate status effectively.Contribute to successful project execution.Regulatory Compliance & Quality AssuranceEnsure compliance with:GMP (Good Manufacturing Practices)GLP (Good Laboratory Practices)SOP RequirementsRegulatory GuidelinesQuality StandardsMaintain accurate documentation and laboratory records.Support audits, inspections, and quality initiatives.Promote a culture of compliance and scientific integrity.Continuous ImprovementIdentify opportunities to improve:Testing ProcessesLaboratory EfficiencyScientific MethodologiesProduct Development ActivitiesParticipate in cross-functional improvement initiatives.Support innovation and scientific advancement.Contribute to departmental and organizational goals.QualificationsEducation RequiredBachelor's Degree in:ChemistryBiochemistryPharmaceutical SciencesLife SciencesRelated Scientific DisciplinePreferredMaster's DegreePhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or related fieldExperience Required3-5 years of relevant scientific experience.Experience in:Analytical ChemistryBiochemistryLaboratory OperationsPharmaceutical DevelopmentFormulation DevelopmentPreferredExperience in pharmaceutical, biotechnology, contract research, or analytical laboratory environments.Experience supporting clinical development programs.Technical SkillsAnalytical ChemistryHPLCGCLC-MSFTIRMethod DevelopmentMethod ValidationBiochemistry & Molecular AnalysisddPCRBiomolecule CharacterizationBiological TestingMolecular AnalysisFormulation & Process DevelopmentSmall Molecule FormulationBiologics FormulationDrug Product DevelopmentManufacturing Process OptimizationStability StudiesQuality & ComplianceGMPGLPSOP ComplianceRegulatory DocumentationQuality SystemsData AnalysisScientific Data InterpretationStatistical AnalysisTrend AnalysisRoot Cause InvestigationTechnical ReportingLeadership CompetenciesScientific LeadershipTeam MentoringTraining & DevelopmentProject CoordinationCross-Functional CollaborationTechnical CommunicationProblem SolvingStakeholder ManagementCore CompetenciesAnalytical Chemistry