Senior Specialist, Bioanalytical Outsourcing

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

Senior Specialist, Bioanalytical Outsourcing

Espoo, Finland and 1 more (Hybrid)

Job Description

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.
• 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 stride 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.

• 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.

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.

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

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.