Head of Product & Process Development (Drug Delivery)

ARx; Northern (KY); Hybrid; USD 150,000 - 210,000; Full time

Job summary

ARx is seeking an experienced Director of Product and Process Development to lead ARx’s PDP program, including development and scale-up, technology transfer and validation of formulations and manufacturing processes for specialty drug delivery products in compliance with 21CFR211 and ARx standards.

This role manages PDP engineers, partners with Quality, Operations, Marketing and clients to achieve successful outcomes, guides design of experiments, data analysis and reporting, ensures proper

Qualifications

• Bachelor’s degree in Science, Engineering, or technical discipline.
• Minimum of 8 years relevant industry experience.
• Strong understanding of drug formulation and process technology.
• LEAN and SIX SIGMA experience desired.
• Excellent leadership and communication skills.

Responsibilities

• Lead PDP process development, scale-up and tech transfer.
• Collaborate with Quality, Operations, Marketing and clients to achieve successful outcomes.
• Manage PDP team through experiments, data collection and reporting.
• Maintain design records for formulas and processing methods.
• Ensure compliance with 21 CFR 211 and regulatory requirements.

Skills

Team leadership

Statistical analysis

Project management

Education

Bachelor's degree in Science/Engineering

Graduate degree preferred

Tools

SPC

ANOVA

Regression analysis

Job description

ARx is seeking an experienced Director of Product and Process Development to lead ARx’s PDP program, including development and scale-up, technology transfer and validation of formulations and manufacturing processes for specialty drug delivery products in compliance with 21CFR211 and ARx standards.

This role manages PDP engineers, partners with Quality, Operations, Marketing and clients to achieve successful outcomes, guides design of experiments, data analysis and reporting, ensures proper