Senior Specialist, Bioanalytical Outsourcing

About this role

Responsibilities

• We are seeking an experienced Senior Specialist, Bioanalytical Outsourcing with strong scientific and regulatory know-how on bioanalysis in both biologics and small molecules to join our Quantitative Bioanalytical & Biomarker organization in R&D. In this role, you will serve as the primary scientific and operational lead for outsourced quantitative bioanalytical activities at Contract Research Organisations (CROs) ensuring high-quality assay execution, regulatory compliance, and timely delivery of data critical for decision-making throughout the drug development process. You will also act as Sourcing Manager taking care of purchasing the quantitative bioanalytics from CROs. The main tasks for this position are to source and manage method development, validation and sample analysis at CROs supporting non-clinical (non-GLP and GLP) and clinical studies in close collaboration with other Orion stakeholders.
• This is a full-time scientific position within the Bioanalytical outsourcing group within the Quantitative Bioanalytical and Biomarker organization in R&D based in Espoo or Turku, Finland or Cambridge UK. In this role, you will report to Head of Quantitative Bioanalytics & Biomarkers.
• Provide scientific and operational oversight of outsourced bioanalytical activities, including:Drug and biomarker quantitation assays (LBA and LC-MS/MS)
• Immunogenicity testing (ADA including NAb)
• Manage bioanalytical studies from study planning through final reporting, ensuring alignment with project timelines and quality expectations.
• Interact with CRO and coordinate bioanalytical agreements and CRO documents. Facilitate regular meetings with external laboratories to review progress, identify risks, and implement mitigation strategies.
• Collaborate with internal teams to ensure bioanalysis is performed according to project expectations.
• Monitor CRO performance, deliverables, budgets, milestones, and contractual commitments.Ensure method