Analytical Development Scientist

Title: Analytical Development Scientist - BiologicsLocation: Andover, MA 01810100% OnsiteDuration: 12 Months contractPosition SummaryThis role provides a combination of analytical laboratory testing and non-laboratory support to the QC Product Technical Support department in support of product lifecycle management. The scope includes analysis of biological products as well as authoring documentation to support lifecycle activities.Responsibilities include analytical method optimization, method validation, comparability assessments, and the evaluation of new technologies.The role requires a solid understanding of scientific principles underlying test methods, method validation requirements, data analysis, and cGMP requirements.Core ResponsibilitiesProvide technical support for new or established analytical methods, troubleshooting methods and method improvements.Analyze and interpret results with a solid scientific understanding, ensuring accuracy, completeness, and compliance.Author test methods, validation protocols and reports, as well as supporting technical documentation for product lifecycle management.Identify technical issues, method performance issues, instrument malfunctions and methodology problems and participate in necessary investigations.Maintain all related data and records in compliance with cGMPs and quality procedures.Track timelines and deliverables, and communicate effectively across teams to ensure alignment and timely execution.Basic QualificationsEducationB.S. in Chemistry, Biology or related scientific discipline with a minimum of 5 years of applicable laboratory experienceORM.S. with a minimum of 3 years of relevant experienceTechnical Knowledge & ExperienceKnowledge and practical application of relevant analytical techniquesExperience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operationsExperience in method troubleshooting and laboratory investigationsExperience in validation of analytical methodsExperience with cGMPs and regulatory guidanceAnalytical TechniquesHPLCCEGelSpectroscopy