Senior Drug Product Lead - Remote, Multi-Program Impact

EPM Scientific; New York (NY); On-site; USD 190,000 - 220,000; Full time

Job summary

EPM Scientific is seeking an Associate Director of Drug Product Development in the United States. The role leads formulation, process development, scale-up, and tech transfer for multiple small molecule programs, driving CMC strategy across the lifecycle.

The candidate will manage external CDMOs, ensure CQAs are considered during scale-up, and collaborate with regulatory, quality, and process development teams to align development with regulatory expectations and commercial timelines.

Qualifications

• Experience leading drug product development across late-stage and commercial readiness.
• Strong formulation and process development know-how with scale-up and tech transfer.
• Experience managing outsourced development and manufacturing programs through CDMOs or external partners.
• Understanding of CQAs and impact of scale-up on quality and regulatory compliance.
• Experience supporting regulatory submissions and health authority interactions.

Responsibilities

• Lead drug product development strategy for assigned small molecule programs.
• Direct formulation development, process development, scale-up, and technology transfer activities.
• Design and oversee development of phase-appropriate clinical formulations aligned with program objectives and timelines.
• Author, review, and approve CMC documentation for regulatory submissions.
• Manage external development and manufacturing organizations to ensure quality, compliance, and timely execution.
• Partner with internal functions including process development, analytical development, regulatory affairs, quality, supply chain, and project management.
• Collaborate cross-functionally with non-CMC stakeholders supporting clinical and development programs.
• Provide technical leadership for investigations, troubleshooting, risk assessments, and change management.
• Ensure compliance with GMP, ICH, and global regulatory standards.
• Support manufacturing campaigns and development activities through periodic travel as needed.

Skills

Drug product development

Formulation development

Process optimization

Manufacturing scale-up

Technology transfer

Regulatory submissions

CQAs understanding

Leadership

Project management

Communication

Cross-functional collaboration

Education

PhD in Pharmaceutical Sciences / related

MS degree in a relevant field

Job description

EPM Scientific is seeking an Associate Director of Drug Product Development in the United States. The role leads formulation, process development, scale-up, and tech transfer for multiple small molecule programs, driving CMC strategy across the lifecycle.

The candidate will manage external CDMOs, ensure CQAs are considered during scale-up, and collaborate with regulatory, quality, and process development teams to align development with regulatory expectations and commercial timelines.