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Hansa Biopharma is seeking an experienced Manufacturing Science & Technology expert with deep hands-on expertise in biologics manufacturing and GMP quality systems. In this role, you will take lead on the CMC processes and play a critical part in ensuring operational excellence. You will actively shape and strengthen the biologics CMC quality framework, ensuring the quality and regulatory compliance of externally manufactured drug substance and drug product batches. Acting as a go-to expert, you will provide guidance on complex GMP and manufacturing topics related to our innovative protein-based therapies, combining both strategic direction and operational oversight. As Senior CMC Manager, MSAT (Biologics) working within CMC project teams, you will represent an independent quality perspective at the interface with Quality Assurance, supporting robust decision-making across the organization. You will report to the Head of CMC Early-Stage Development and Manufacturing and work cross-functionally in a science-driven, dynamic organization.
Job Responsibility
Act as the recognized internal SME for CMC Quality related to biologics and GMP compliance for biological drug substance and drug product manufacturing
Strengthen and continuously improve CMC quality systems, promoting a proactive, science-based, and compliance-driven quality culture while identifying process improvement opportunities
Coordinate and manage deviation investigations, change controls, CAPAs, and risk assessments
Contribute to, and support, interactions with regulatory authorities (e.g., FDA, EMA)
Review and approve Master Batch Records, protocols, validation documentation, and technical reports
Provide robust quality oversight of CDMOs, CMOs, and CROs, including supplier qualification, performance monitoring (KPIs), and continuous improvement initiatives
Act as vendor responsible and perform periodic Vendor review
Contribute to the establishment and maintenance of Quality Agreements
Requirements
M.Sc (or equivalent) in Pharmaceutical Sciences, Biochemistry, Biotechnology, Chemistry, Engineering, or related life science field
Typically, 8+ years of experience in GMP manufacturing of biologics
Demonstrated in-depth scientific understanding of biologics manufacturing processes (e.g., recombinant proteins, enzymes, monoclonal antibodies or similar)
Extensive experience supporting both clinical development and commercial manufacturing
Solid hands-on experience working within GMP-regulated quality systems
Proven track record in oversight of CDMOs/CMOs in a virtual or outsourced manufacturing structure
Experience interacting with global health authorities and supporting regulatory inspections
Strong understanding of regulatory expectations for biologics throughout the product lifecycle