Overview In this role, you will lead a small team to oversee GMP sample management and stability programs, ensuring accurate tracking, timely coordination, and compliant documentation. You'll craft sampling plans, testing specs, and stability protocols in collaboration with QC, QA, Manufacturing, and external labs. You will manage multi-project schedules, maintain traceability, and drive continuous improvement in workflows. This position sits at the intersection of logistics, quality, and client coordination within a fast-growing biologics environment. Compensation / BenefitsMedicalDentalVision401K (match up to 5%, plus an additional 3%)Paid time offAnnual Bonus eligible ResponsibilitiesLead a 2-3 person team for daily sample management activitiesOversee receipt, accessioning, labeling, storage, shipment, and disposition of samplesMaintain sample traceability and chain of custody across the lifecycleEstablish and manage stability study schedules and pull calendarsGenerate, revise, and maintain sampling plans and testing specificationsGenerate and maintain stability protocols aligned with program requirementsAuthor and review GMP documentation (SOPs, forms, records) and ensure traceabilityCoordinate cross-functional and client communications for sampling and testingLead or support investigations, CAPAs, and deviations related to sample handling and stabilityTrain staff and drive process improvements to enhance compliance and efficiency Key requirementsBS or higher in Physical or Biological Sciences or related fieldGMP sample management and stability administration experienceExperience with LIMS or similar tracking systemsStrong attention to detail and quality focusProven leadership of a small team (2-3)Effective verbal and written communication; coordination with clients and internal teamsleadershipattention to detailstrong organizational skillsLIMS or other sample tracking systemsdevelopment and maintenance of sampling plans and testing specificationsstability protocols and study scheduling
Not specified in the original listing.
Not specified in the original listing.
