Senior Director, MS&T, Biologics Platform
EPM Scientific · Philadelphia, PA · 1 mo ago
ScienceFull-time
About the role
The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function providing strategic direction and technical and operational leadership across a global manufacturing network. MSAT serves as the steward of manufacturing process knowledge, ensuring alignment of commercial operations with registered processes and driving robustness, compliance, performance, and cost efficiency across the product lifecycle.
Responsibilities
- Platform & Technology Leadership: Accountable for biologics manufacturing technology platforms (MTTs), ensuring effective, scalable, and future-ready capabilities are in place to support evolving modalities
- Drug Substance & Process Development Integration: Drive strong integration between process development (early and late stage) and commercial manufacturing, ensuring seamless translation of processes from development through scale-up and into routine production
- Manufacturing & Commercial Operations Leadership: Provide technical leadership and oversight to ensure commercial-scale manufacturing performance, reliability, and continuous improvement
- Network & Execution: Lead cross-functional and cross-site collaboration across MSAT, Manufacturing, Engineering, and Quality organizations
- Troubleshooting & Lifecycle Management: Provide leadership in advanced technical troubleshooting, root cause analysis (RCA), and CAPA effectiveness
- Governance & Stakeholder Engagement: Maintain strong engagement with R&D, Regulatory, Quality, and Supply Chain partners
Qualifications
- BSc / MSc / PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmacy, or related fields
- PhD with 15+ years, MS with 18+ years, or BS with 20+ years of relevant experience
Skills
- Deep expertise in biology, drug substance manufacturing, including upstream processing (cell culture, bioreactors, fermentation) and downstream purification (chromatography, filtration, viral clearance)
- Strong understanding of end-to-end process development through commercialization, including process characterization and validation, technology transfer, and control strategy development
- Experience in large-scale GMP manufacturing environments and proven success in process scale-up and industrialization from clinical to commercial scale
- Strong knowledge of regulatory expectations (GMP, FDA, EMA) and experience in applying digital tools, modeling, and data analytics in biologics manufacturing
- Demonstrated leadership in structured problem solving and technical decision-making, and strong communication and influencing skills across technical and executive audiences