Director of Product and Process Development

Director of Product and Process Development

Work Location: York County, Pennsylvania

Summary:

Oversee the development, scale-up, technology transfer, and validation of formulations, manufacturing processes, and packaging for specialty drug delivery products, ensuring compliance with regulatory and quality standards.

Responsibilities:

• Direct the development and implementation of new products aligned with business priorities and customer requirements.
• Lead all aspects of process and packaging development, including scale-up, validation, and technology transfer activities.
• Supervise and mentor engineering teams, ensuring project tasks are executed in compliance with regulatory standards.
• Collaborate with cross-functional teams such as Quality, Operations, and Marketing to achieve project goals.
• Guide experimental design, data collection, statistical analysis, and reporting for product and process development projects.
• Maintain comprehensive records for formulas, processing methods, and product standards to support organizational efficiency.
• Utilize software tools for communication, project tracking, and statistical analysis to enhance project execution.
• Drive problem-solving initiatives, lead change-control procedures, and contribute to strategic technology and IP planning.

Qualifications:

• Bachelor’s degree in Science, Engineering, or a technical discipline required; graduate degree preferred.
• Minimum of 8 years of relevant industry experience (e.g., thin film, transdermal, process development).
• Strong understanding of drug formulation and process technology.
• Experience with cGMP and design record documentation preferred.
• Expertise in design control processes and Quality-By-Design (QbD) methodologies.
• Familiarity with clinical trials and FDA regulatory filings is a plus.
• Background in formulations, film casting, and converting is desirable.
• Demonstrated success in project management and leading teams.
• Ability to manage multiple projects simultaneously and facilitate team collaboration.
• Excellent oral and written communication skills.
• Strong attention to detail with the ability to balance project and business objectives.
• Ability to perform under pressure and meet deadlines.
• Experience with LEAN and SIX SIGMA methodologies preferred.

Published Category: Analytical & Process Development