ANALYTICAL DEVELOPMENT PRINCIPAL – DS & DP BIOSIMILARS

Polpharma Biologics Group; Risch-Rotkreuz; On-site; CHF 180,000 - 280,000; Full time

Job summary

Polpharma Biologics Group in Switzerland seeks an Analytical Development Leader to own the DS and DP biosimilar analytical strategy from early development through regulatory submission. You will lead method development, validation, and tech transfer in a cross-functional, global setting.

In this SME role, you will partner with Process Development, Quality, Regulatory Affairs, and external CDMOs to ensure data integrity, timelines and compliant lifecycle management.

Qualifications

• 10+ years in biopharmaceutical analytical development for biologics or biosimilars.
• Advanced degree in a life science field.
• Deep knowledge of analytical methods, bio similarity and CQA strategies.
• Proficient with cGMP and ICH/EMA/FDA requirements.
• Experience managing CRO/CDMO partners in outsourced or virtual models.
• Independent, hands-on and collaborative in a global matrix environment.
• Fluent English and willingness to travel internationally.

Responsibilities

• Own end-to-end analytical strategy and control strategy for DS and DP biosimilar programmes.
• Lead analytical method development, qualification, validation, transfer, and lifecycle management.
• Provide SME oversight for bio similarity, comparability, reference product characterisation, and complex investigations.
• Select and manage CRO/CDMO partners, ensuring data integrity, timelines, budgets, and regulatory compliance.
• Support CMC regulatory submissions, health authority interactions, inspections, and partner audits.
• Collaborate with Process Development, Quality, Regulatory Affairs, Programme Management and external partners to ensure integrated delivery.

Skills

Analytical leadership

Bio similarity expertise

CQA frameworks

Global collaboration

CRO/CDMO oversight

Education

Master's degree in biochemistry/analytical chemistry/biotechnology/pharmacy

PhD in life sciences

Job description

We are looking for an experienced analytical development leader to join our Technology organisation as the analytical SMEa subject matter expert for drug substance (DS) and drug product (DP) biosimilars. In this high-impact role, you will build and own the analytical strategy from early development through regulatory submission and commercial lifecycle management.

Job Purpose

The Analytical Development Principal – DS & DP Biosimilars will serve as the subject matter expert (SME) for analytical science across drug substance and drug product development in a virtual/CDMO-model biosimilar organisation. Working within a cross-functional team and in close partnership with external CDMOs and CROs, the role holder will own and build the analytical strategy from early development through to regulatory submission and commercial lifecycle management. This includes analytical characterisation, method development and qualification, bio similarity assessment, method validation, method tech transfer and control strategy design for biologics/biosimilars. The job holder will report directly to the Head of TD&MFG.

Scope of duties:

• Own the end-to-end analytical strategy and control strategy for biosimilar DS and DP programmes, including CQAs, characterisation, release testing, and stability.
• Lead analytical method development, qualification, validation, transfer, and lifecycle management.
• Provide SME oversight for bio similarity, comparability, reference product characterisation, and complex analytical investigations.
• Select and manage CRO/CDMO partners, ensuring data integrity, quality, timelines, budgets, and regulatory compliance.
• Support CMC regulatory submissions, health authority interactions, inspections, and partner audits.
• Collaborate with Process Development, Quality, Regulatory Affairs, Programme Management, and external partners to ensure integrated programme delivery and continuous improvement.

Required qualifications:

• 10+ years of biopharmaceutical industry experience, primarily in analytical development for biologics or biosimilars.
• Master’s degree or PhD in biochemistry, analytical chemistry, biotechnology, pharmacy, or a related life science.
• Deep expertise in analytical methods, bio similarity/comparability, CQA frameworks, and control strategies for biologic DS and DP.
• Strong knowledge of cGMP and relevant ICH, EMA, and FDA requirements.
• Proven experience managing CRO/CDMO partners in an outsourced or virtual model.
• Independent, hands-on, and collaborative working style in a global matrix environment.
• Fluent English and willingness to travel internationally.

Ready to make an impact?

Help us if you are passionate about analytical science and want to help bring high-quality biosimilars to patients. We would be pleased to hear from you.