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. #J-18808-Ljbffr
ANALYTICAL DEVELOPMENT PRINCIPAL – DS & DP BIOSIMILARS Arbeitgeber: Polpharma Biologics Group
Polpharma Biologics ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, eine Schlüsselrolle in der Entwicklung innovativer Kombinationstherapien zu übernehmen. Mit einem internationalen, kollaborativen Team und einem flexiblen hybriden Arbeitsmodell fördern wir eine Kultur des Wachstums und der Verantwortung, während Sie an bedeutenden Projekten arbeiten, die einen direkten Einfluss auf die Zukunft unserer Produktpalette haben. Unsere Mitarbeiter profitieren von umfassenden Entwicklungsmöglichkeiten und einem wettbewerbsfähigen Vergütungspaket, das Ihre Karriere im Bereich der biopharmazeutischen Technologien unterstützt.
Kontaktdaten:
Polpharma Biologics Group Recruiting-Team
