Director, Product & Process Development

Scientific Search; Glen Rock (York County); Presencial; USD 180.000 - 260.000; Jornada completa

Descripción de la vacante

Scientific Search is seeking a Director of Product & Process Development to lead the science behind next-generation drug delivery products in Glen Rock, PA. The role oversees formulation, process development, scale-up, validation, tech transfer, and commercialization within a cGMP environment.

You will drive QbD, design controls, and CAPA programs while mentoring PDP team members and collaborating with Quality, Operations, and customers to deliver high-impact programs.

Formación

• Bachelor’s degree in science, engineering, or technical discipline required; advanced degree preferred.
• Expertise in thin-film, transdermal, formulation, or process development.
• Strong knowledge of 21 CFR 211, cGMP, QbD, and design controls.
• Skilled in statistical analysis, experimental design, and project management.
• LEAN/Six Sigma, film casting/converting, and FDA filing familiarity valued.

Responsabilidades

• Lead formulation, process, packaging, scale-up, validation, and tech transfer.
• Direct experimental design, statistical analysis, QbD, and design controls.
• Lead deviation investigations, CAPAs, and change-control initiatives.
• Manage multiple development programs and technical documentation.
• Coach, mentor, and manage PDP team members.

Conocimientos

Statistical analysis

Experimental design

Project management

LEAN/Six Sigma

FDA filing familiarity

QbD/design controls

Leadership

Educación

Bachelor’s in Science/Engineering/technical discipline

Graduate degree preferred

Descripción del empleo

Director of Product & Process Development

Location: Glen Rock, PA

Lead the science behind next-generation specialty drug delivery products. My client is seeking a technical leader to drive product and process development from formulation and scale-up through validation, technology transfer, and commercialization in a highly regulated environment.

Why You Should Apply

• Shape innovative drug delivery products from concept through manufacturing
• Lead and develop a talented process engineering team
• Influence technology, product, and IP strategy
• Collaborate directly with Quality, Operations, customers, and commercial teams
• Drive high-impact technical programs in a cGMP environment

What You’ll Be Doing

• Lead formulation, process, packaging, scale-up, validation, and tech transfer
• Direct experimental design, statistical analysis, QbD, and design controls
• Lead deviation investigations, CAPAs, and change-control initiatives
• Manage multiple development programs and technical documentation
• Coach, mentor, and manage PDP team members

About You

• Bachelor’s in Science, Engineering, or technical discipline; graduate degree preferred
• Expertise in thin-film, transdermal, formulation, or process development
• Strong knowledge of 21 CFR 211, cGMP, QbD, and design controls
• Skilled in statistical analysis, experimental design, and project management
• LEAN/Six Sigma, film casting/converting, and FDA filing familiarity valued