Biosimilars Analytical Development Lead (DS/DP)

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

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.