Tech Dev Consultant (CMC Lead)

Princeton, NJ - Pharmaceutical & Biotech - Hybrid - Full time

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Date Posted: 8/4/2025

Technical Development Consultant (CMC Lead)
Princeton, NJ (Hybrid)

Position Summary:
We are seeking a Technical Development Consultant (CMC Lead) to head all aspects of CMC strategy and execution across nanoparticle-based drug development programs. This individual will oversee formulation development, manufacturing, regulatory support, and cross-functional alignment from early discovery through GMP manufacturing.

Key Responsibilities:
Lead technical and CMC strategy across programs, aligning with corporate goals and timelines. Manage and grow cross-functional R&D and CMC teams; oversee hiring and performance. Direct nanoparticle formulation development for preclinical and early-stage programs. Oversee CMOs and external partners for scale-up, GLP, and GMP manufacturing. Prepare CMC documentation for regulatory filings; ensure compliance with global regulatory standards. Lead technology transfer from academic and industry collaborators to manufacturing partners. Facilitate risk assessment and mitigation planning across all technical development activities.

Qualifications:
PhD in Pharmaceutical Sciences, Chemistry, or related field. 10+ years of experience in CMC, formulation development, and technical leadership. Proven track record managing complex drug development programs and external vendors. Expertise in nanoparticle/microparticle formulations and regulatory strategy. Strong leadership, cross-functional collaboration, and project management skills.

Please contact Mini Gururaj at mgururaj@clarkdavis.com

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