Director, Drug Delivery Product & Process Development

ARx Pharma; Glen Rock (York County); On-site; USD 130,000 - 190,000; Full time

Job summary

ARx Pharma is seeking a senior PDP leader to drive formulation development, scale-up, validation, and tech transfer for specialty drug-delivery products.

You will lead the PDP team, coordinate cross-functional work with Quality, Operations, Marketing and clients, and ensure compliance with 21 CFR 211 and ARx PDP requirements.

The role requires 8+ years in related fields, strong project management, LEAN/Six Sigma expertise, and excellent communication.

Qualifications

• Bachelor’s degree in Science, Engineering, or technical discipline required; graduate degree preferred.
• Minimum 8 years in relevant pharma processing or thin film technology.
• Ability to understand technical aspects of drug formulation and process technology.
• Familiarity with clinical trials & FDA regulatory filings desired.
• Previous experience with LEAN and SIX SIGMA desired.
• Proven history of successful project management.
• Excellent team leadership and facilitation skills.

Responsibilities

• Lead PDP process development, scale-up, validation and tech transfer.
• Manage PDP team and cross-functional collaboration with QA, Operations, Marketing and Clients.
• Coordinate design of experiments and data collection/analysis (statistical methods).
• Ensure records for formulas, processing methods and product construction standards.
• Oversee change-control procedures and CAPA to drive continuous improvement.

Skills

Project management

Team leadership

Statistical analysis

Lean Six Sigma

Communication skills

Cross-functional collaboration

Education

Bachelor's degree

Graduate degree preferred

Tools

Statistical analysis tools

MS Office

Project management software

Job description

ARx Pharma is seeking a senior PDP leader to drive formulation development, scale-up, validation, and tech transfer for specialty drug-delivery products.

You will lead the PDP team, coordinate cross-functional work with Quality, Operations, Marketing and clients, and ensure compliance with 21 CFR 211 and ARx PDP requirements.

The role requires 8+ years in related fields, strong project management, LEAN/Six Sigma expertise, and excellent communication.