Remote Part-Time Drug Substance Expert (Small Molecule)

The Steely Group; Jersey City (NJ); Híbrido; USD 96.000 - 165.000; A tiempo parcial

Descripción de la vacante

The Steely Group seeks a consultant with broad expertise in medicinal and process chemistry to lead drug substance development from discovery through commercialization. The role calls for strategic direction, technical depth in synthesis routes, scale-up, and regulatory documentation for IND/NDA filings.

Ideal candidates have extensive experience in drug substance manufacturing, QbD principles, and CRO/CDMO oversight, enabling successful tech transfer and robust process performance.

Formación

• PhD or MS with extensive pharma/biotech experience.
• End-to-end drug substance development and manufacturing knowledge.
• Familiarity with regulatory filings (CMC sections).

Responsabilidades

• Provide strategic and technical leadership for discovery, optimization, development, and manufacture of small-molecule drug substances.
• Develop drug substance synthesis routes, manufacturing processes, and transfer to manufacturing.
• Oversee scale-up, process characterization, and qualification strategies.

Conocimientos

Medicinal chemistry

Process chemistry

Drug substance development

CMC writing

Educación

PhD in Organic/ Medicinal Chemistry

Descripción del empleo

The Steely Group seeks a consultant with broad expertise in medicinal and process chemistry to lead drug substance development from discovery through commercialization. The role calls for strategic direction, technical depth in synthesis routes, scale-up, and regulatory documentation for IND/NDA filings.

Ideal candidates have extensive experience in drug substance manufacturing, QbD principles, and CRO/CDMO oversight, enabling successful tech transfer and robust process performance.