Innovation Lead, Product & Process Development

Adhesives Research; Glen Rock (York County); On-site; USD 120,000 - 160,000; Full time

Job summary

Adhesives Research seeks a Director of Product and Process Development to lead PDP activities for drug-delivery product development. You will drive scale-up, tech transfer, validation and packaging development, while coordinating with Quality, Operations, Marketing and clients to achieve strong outcomes.

The role requires 8+ years in process development, expertise in formulation technology, and familiarity with 21 CFR 211.

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.
• Ability to oversee multiple projects simultaneously.
• Strong oral and written communications skills.
• Exceptional ability to manage detail in the context of overall project and business strategies; ability to make sound decisions balancing competing considerations.

Responsibilities

• Leads PDP process development, scale-up, validation and tech transfer.
• Manages packaging development, scale-up, validation and tech transfer.
• Supervises Process Engineers during project tasks and compliance with 21CFR211.
• Collaborates with Quality, Operations, Marketing and Clients for successful outcomes.
• Leads experiments, data collection and analysis using SPC, ANOVA, Regression, etc.
• Ensures design records support product development per ARx PDP.
• Maintains records for formulas, processing methods and product construction standards.
• Uses software tools for communications, presentations, project tracking and statistics.

Skills

Leadership

Project management

Communication

Analytical thinking

Problem solving

Education

Bachelor's degree in Science/Engineering/technical

Graduate degree preferred

Tools

Excel

PowerPoint

Project management software

Statistical analysis tools

Job description

Adhesives Research seeks a Director of Product and Process Development to lead PDP activities for drug-delivery product development. You will drive scale-up, tech transfer, validation and packaging development, while coordinating with Quality, Operations, Marketing and clients to achieve strong outcomes.

The role requires 8+ years in process development, expertise in formulation technology, and familiarity with 21 CFR 211.