Associate Director, Strategic Manufacturing Solutions (DSP)
Core
Technical leadership for the development, transfer, scale-up, and GMP implementation of biologics downstream processes (mAbs, complex molecules) to ensure manufacturing readiness and regulatory compliance.
Role type
Senior IC manufacturing scientist (biologics downstream)
Builds
GMP manufacturing operations for biologics
Domain
Biopharmaceuticals / Biologics manufacturing
Required skills
Downstream processing (chromatography, TFF/UFDF, viral clearance, filtration), process scale-up, process characterization, validation, troubleshooting, technology transfer, regulatory compliance (EU/US GMP), cross-functional leadership, stakeholder influence
Preferred skills
Biosimilar development, process conversions, FDA/EMA inspection experience
Technologies
Chromatography, TFF/UFDF, filtration systems
Responsibilities
Lead technology transfer from development to GMP manufacturing, troubleshoot production campaigns, develop regulatory readiness roadmaps for FDA/EMA, provide technical expertise for customer proposals and pitches, document processes per GMP best practices
Seniority
Senior, hands-on IC
