Project Lead Drug Substance (w / m / d)

Join a global biopharmaceutical company advancing innovative therapies in oncology and rare diseases. With a strong pipeline and a collaborative, science-driven culture, this organization empowers its leaders to shape the future of biologics manufacturing.

We are seeking a strategic and hands-on leader to drive the technology transfer of drug substance manufacturing processes , with a strong focus on Antibody-Drug Conjugates (ADCs) . This role is critical in ensuring seamless scale-up and commercialization of complex biologics across internal and external manufacturing sites.

Key Responsibilities

• Lead cross-functional site launch teams for DS manufacturing (clinical and commercial)
• Oversee tech transfer, PPQ, and validation activities in line with global CMC strategy
• Act as the technical interface between development, manufacturing, QA, and regulatory teams
• Evaluate CDMOs for clinical and commercial manufacturing, support facility fit assessments
• Contribute to regulatory submissions (IND, IMPD, BLA, NDA) and inspection readiness
• Recommend and implement new technologies to improve DS manufacturing performance
• Support data-driven decision-making and digitalization of tech transfer processes

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