Senior Specialist, Bioanalytical Outsourcing

Your role

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.

Responsibilities

• 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 development, validation, and bioanalytical plans and reports are executed according to regulatory expectations and project needs.
  • Review bioanalytical data during study conduct and verify adherence to analysis and reporting schedules.
  • Troubleshoot scientific and operational issues affecting study execution and proactively communicate risks and solutions to internal stakeholders.
  • Coordinate sample management activities, including sample tracking and shipment oversight.
  • Support regulatory submissions.
• Evaluate CROs and source quantitative bioanalytical studies from CROs.

Expectations

• Act as a trusted scientific partner and subject matter expert in outsourced bioanalysis.
• Deliver high-quality bioanalytical support to clinical and non-clinical (GLP and non-GLP) studies.
• Build and maintain strong relationships with internal stakeholders and CROs.
• Expertise in sourcing services from CROs is an advantage.
• Drive proactive problem solving and continuous improvement across outsourced bioanalytical activities.
• Effectively manage multiple priorities in a fast-paced drug development environment.
• Communicate complex scientific and operational information clearly to multidisciplinary teams.
• Ensure projects remain on schedule while maintaining regulatory compliance and scientific excellence.
• Be willing to travel domestically and internationally as required to support CRO partnerships.

What you can expect from us

At Orion Pharma, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life.

Please visit our website to find further information about our values and Orion as an employer https://www.orionpharma.com/careers/working-with-us/.

What We Are Looking For

Education & Experience

• At least MSc degree in a relevant scientific discipline with strong industry experience.
• Extensive experience in quantitative bioanalysis and drug development especially with biologics.
• Strong understanding of the drug development process from discovery through regulatory submission and product approval.
• Extensive experience with:
  • Ligand Binding Assays (LBA)
  • Immunogenicity testing (ADA including NAb)
  • LC-MS/MS assays for large and small molecule therapeutics
  • Bioanalytical strategies supporting non-clinical and clinical development
• Demonstrated experience managing outsourced bioanalytical studies and CRO relationships.
• Strong knowledge of:
  • Good Laboratory Practice (GLP)
  • Good Clinical Practice (GCP)
  • Global regulatory guidance for bioanalytical method validation and immunogenicity assessment
• Experience supporting global development programs and international collaborations.

Personal Attributes

• Excellent organizational and project management skills.
• Strong scientific problem-solving capability.
• Outstanding written and verbal communication skills.
• Detail-oriented with a commitment to quality and compliance.
• Strong interpersonal skills with the ability to influence and collaborate across multidisciplinary teams.
• Proven ability to manage complex projects and deliver results under demanding timelines.

How to apply

If you are interested in this opportunity, please submit your application by October 18th, 2026. We may begin interviewing candidates during the application period. We kindly ask recruitment agencies and headhunters not to contact us regarding this vacancy.

For further information about the position, please contact: Mika Pykäläinen, Head of Quantitative Bioanalytics & Biomarkers: mika.pykalainen (at) orionpharma.com

Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person.

#LI-ORION

Your new team

Orion’s pharmaceutical innovations are created within its R&D organization. We employ over 400 top professionals in the field of drug discovery and development. We work globally: in Espoo and Turku in Finland, in Nottingham and Cambridge in the UK, and in Cambridge, MA, USA. Orion R&D and the Innovative Medicines business division are dedicated to making a transformation to become a global player in the pain and oncology therapy areas.

The Quantitative Bioanalytics & Biomarkers unit is part of Orion's R&D Integrated DMPK&Safety department. The unit consists of a laboratory in Espoo, Finland, and Bioanalytical Outsourcing functions.

The laboratory is responsible for the quantification of drug candidates and biomarkers in a variety of biological matrices, primarily supporting Orion’s early-stage drug discovery and development projects. The Bioanalytical Outsourcing function oversees bioanalytical studies conducted by external partners, ranging from non-clinical GxP studies to clinical development programs.

We support both biologics and small molecule (SME) drug development with a particular focus on Orion’s oncology and pain therapeutic areas.