Head of R&D, Drug Delivery & IP Strategy

ARx Pharma; Glen Rock (York County); On-site; USD 180,000 - 270,000; Full time

Job summary

ARx Pharma seeks a visionary leader to head its Research and Development Department, driving new product development, formulations, and technologies aligned with business priorities and customer needs.

The role ensures CMC compliance, regulatory filings, and seamless technology transfer from R&D to manufacturing, while advancing ARx’s leadership in drug delivery innovations. Extensive pharma R&D, IP management, and regulatory expertise are essential.

Qualifications

• Advanced degree (PhD) in a scientific and/or engineering discipline focusing on chemistry/pharmaceutical sciences.
• 20+ years technical and 10+ years laboratory environment management in pharma/drug-delivery.
• Familiarity with FDA 21 CFR 211 and regulatory requirements for drug products.
• In-depth CMC documentation preparation and regulatory guidelines knowledge.
• Experience with IP management for pharma technologies, including patents.
• Strong leadership and communication across functions; travel 10–15%.

Responsibilities

• Lead ARx Research and Development to develop new products, formulations and technologies.
• Develop and implement division-wide technical policies and programs for profitable growth.
• Oversee CMC compliance and regulatory filings preparation (IND, NDA, etc.).
• Guide tech transfer from R&D to manufacturing for scale-up and commercialization.
• Coordinate invention disclosures and patent filings with Patent Counsel.
• Maintain records of formulations, methods and standards; ensure safety and training.

Skills

Leadership

Regulatory compliance

IP management

Project management

Communication

Pharmaceutical sciences

Education

PhD in Chemistry/Pharmaceutical sciences

Tools

Statistical analysis software

Job description

ARx Pharma seeks a visionary leader to head its Research and Development Department, driving new product development, formulations, and technologies aligned with business priorities and customer needs.

The role ensures CMC compliance, regulatory filings, and seamless technology transfer from R&D to manufacturing, while advancing ARx’s leadership in drug delivery innovations. Extensive pharma R&D, IP management, and regulatory expertise are essential.