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
Your Profile
* PhD or equivalent in biochemistry, biotechnology, or related field
* 8+ years in biopharma with deep experience in drug substance tech transfer and CMC
* Strong knowledge of GMP, regulatory frameworks, and biologics manufacturing
* Experience with ADCs or other complex biologics is highly desirable
* Proven leadership in cross-functional and global environments
What's in it?
* High-impact role in a global matrix organization
* Work on cutting-edge biologics with real-world patient impact
* Hybrid flexibility and international collaboration
* Opportunity to shape the future of ADC manufacturing
Die Personalberatung SThree betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.