Senior Bioanalytical Outsourcing Lead

Orion Corporation; Espoo; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

Orion Pharma is seeking a Senior Specialist, Bioanalytical Outsourcing to lead outsourced quantitative bioanalysis programs for non-clinical and clinical studies. Based in Espoo, Turku, or Cambridge UK with hybrid work, you will coordinate CROs, ensure GLP/GCP compliance, and deliver high-quality data to inform development decisions.

You will manage method development, validation, sample analysis and regulatory submissions, collaborating with internal stakeholders and partners to drive timely,

Qualifications

• MSc degree in a relevant scientific discipline and extensive industry experience.
• Extensive experience in quantitative bioanalysis and drug development, especially biologics.
• Strong understanding of drug development from discovery to regulatory submission.
• Experience with LBA, immunogenicity testing, and LC-MS/MS assays.
• Experience managing outsourced bioanalytical studies and CRO relationships.
• Knowledge of GLP, GCP, and global regulatory guidance.
• Experience supporting global development programs and international collaborations.

Responsibilities

• Provide scientific and operational oversight of outsourced bioanalytical activities, including drug and biomarker quantitation assays (LBA and LC-MS/MS) and immunogenicity testing (ADA including NAb).
• Manage bioanalytical studies from study planning through final reporting, ensuring alignment with timelines and quality.
• Coordinate bioanalytical agreements with CROs and hold regular progress reviews with external labs.
• Collaborate with internal teams to ensure bioanalysis meets project expectations.
• Monitor CRO performance, budgets, milestones, and contractual commitments.
• Ensure methods development, validation, and bioanalytical plans adhere to regulatory expectations.
• Review bioanalytical data during study conduct and communicate risks and solutions to stakeholders.
• Coordinate sample management activities including tracking and shipment oversight.
• Support regulatory submissions and evaluate CROs for sourcing studies.
• Be a SME in outsourced bioanalysis and drive continuous improvement across activities.
• Travel as required to support CRO partnerships.

Skills

Bioanalytical outsourcing

Project management

Scientific communication

Regulatory compliance

CRO relationship management

Stakeholder collaboration

Education

MSc degree in a relevant scientific discipline

Tools

LC-MS/MS

LBA

Immunogenicity testing

Job description

Orion Pharma is seeking a Senior Specialist, Bioanalytical Outsourcing to lead outsourced quantitative bioanalysis programs for non-clinical and clinical studies. Based in Espoo, Turku, or Cambridge UK with hybrid work, you will coordinate CROs, ensure GLP/GCP compliance, and deliver high-quality data to inform development decisions.

You will manage method development, validation, sample analysis and regulatory submissions, collaborating with internal stakeholders and partners to drive timely,