Director of Product & Process Development & Tech Transfer

ARx Pharma; Glen Rock (York County); On-site; USD 150,000 - 210,000; Full time

Job summary

ARx Pharma seeks a senior PDP leader to drive formulation development, scale-up, validation, and technology transfer for specialty drug delivery products. You will coordinate with Quality, Operations, Marketing and clients to ensure compliant, timely delivery of projects.

Ideal candidates have 8+ years in pharmaceutical process development, strong leadership, and deep knowledge of 21CFR211 standards, regulatory filings, and Lean/Six Sigma.

Qualifications

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

Responsibilities

• Leads PDP process development, scale-up, validation and tech transfer.
• Manages PDP team and cross-functional collaboration with Quality, Operations, Marketing and Clients.
• Leads design of experiments, data collection and statistical analysis; generates reports.
• Ensures design records and documentation meet ARx PDP and 21CFR211 requirements.
• Maintains records for formulas, processing methods and product construction standards.
• Supervises direct reports, conducts performance assessments and coaching.
• Handles deviation investigations and implements corrective/preventive actions.

Skills

Leadership

Project management

Statistical analysis

Communication

LEAN/Six Sigma

Education

Bachelor’s degree in Science/Engineering

Graduate degree preferred

Tools

SPC

ANOVA

Regression analysis

PowerPoint

Project Management

Job description

ARx Pharma seeks a senior PDP leader to drive formulation development, scale-up, validation, and technology transfer for specialty drug delivery products. You will coordinate with Quality, Operations, Marketing and clients to ensure compliant, timely delivery of projects.

Ideal candidates have 8+ years in pharmaceutical process development, strong leadership, and deep knowledge of 21CFR211 standards, regulatory filings, and Lean/Six Sigma.