Project Lead Drug Substance (w / m / d)

Real; München; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

A global biopharmaceutical company in Munich is seeking a strategic leader to oversee technology transfer in drug substance manufacturing processes, particularly for Antibody-Drug Conjugates (ADCs). The ideal candidate has a PhD and over 8 years of relevant experience in biopharma, demonstrating strong leadership and knowledge of regulatory frameworks. This role offers hybrid flexibility and the chance to impact patient outcomes directly.

Leistungen

High-impact role in global organization

Opportunity to shape ADC manufacturing

Qualifikationen

• 8+ years in biopharma with deep experience in drug substance tech transfer and CMC.
• Strong knowledge of GMP and biologics manufacturing.
• Proven leadership in cross-functional and global environments.

Aufgaben

• Lead cross-functional site launch teams for DS manufacturing.
• Oversee tech transfer, PPQ, and validation activities.
• Act as the technical interface between development, manufacturing, QA, and regulatory teams.

Kenntnisse

Leadership in cross-functional environments

Knowledge of GMP and regulatory frameworks

Experience with ADCs

Ausbildung

PhD or equivalent in biochemistry or biotechnology

Jobbeschreibung

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

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