Senior Director, Peptide Drug Substance & CMC Strategy

EPM Scientific; Morristown (NJ); On-site; USD 180,000 - 250,000; Full time

Job summary

EPM Scientific seeks an experienced CMC leader to oversee drug substance development and manufacturing from clinical to commercial readiness. The role includes leading process development, scale-up, tech transfer, and lifecycle management, with emphasis on peptide APIs where applicable.

The candidate will manage external CDMOs, ensure regulatory readiness, and collaborate across Quality, Regulatory, and Clinical Supply to align technical and supply objectives.

Qualifications

• PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field; ~10+ years in pharma/biotech.
• Leadership in drug substance process development, tech transfer, and GMP manufacturing.
• Experience managing external CDMOs and complex development programs.
• Strong understanding of process validation, quality systems, regulatory requirements, and lifecycle management.
• Experience authoring/reviewing CMC regulatory submissions and health authority responses.
• Excellent leadership, communication, and cross-functional collaboration skills.

Responsibilities

• Lead drug substance CMC strategy across development, manufacturing, validation, and commercialization activities.
• Provide technical leadership for process development, scale-up, characterization, technology transfer, and lifecycle management.
• Support development and manufacturing of complex APIs, including peptide-based drug substances where applicable.
• Lead external CDMO relationships, manufacturing campaigns, investigations, CAPAs, and process improvements.
• Establish phase-appropriate control strategies using QbD and risk-based approaches.
• Drive process characterization, validation planning, PPQ readiness, and commercial manufacturing preparedness.
• Author and review regulatory CMC documentation and support health authority interactions.
• Partner with cross-functional stakeholders to align technical, regulatory, quality, and supply objectives.

Skills

Drug substance development

Technology transfer

GMP manufacturing

External manufacturing

CMC leadership

Regulatory submissions

Cross-functional leadership

Education

PhD in Chemistry/Pharmaceutical Sciences/Chemical Engineering

MS/BS with relevant experience

Job description

EPM Scientific seeks an experienced CMC leader to oversee drug substance development and manufacturing from clinical to commercial readiness. The role includes leading process development, scale-up, tech transfer, and lifecycle management, with emphasis on peptide APIs where applicable.

The candidate will manage external CDMOs, ensure regulatory readiness, and collaborate across Quality, Regulatory, and Clinical Supply to align technical and supply objectives.