Director of Product & Process Development - Drug Delivery

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

Job summary

ARx Pharma seeks a senior professional to lead and manage the PDP process, including development, scale-up, tech transfer and validation of formulations and manufacturing processes for specialty drug delivery products in compliance with 21 CFR 211 and ARx PDP requirements.

The role requires extensive experience in drug formulation, cGMP, QbD and project leadership, with strong collaboration across Quality, Operations and Clients. Excellent problem-solving and communication skills are essential.

Qualifications

• Bachelor’s degree in Science, Engineering, or technical discipline required.
• Minimum of 8 years relevant industry experience (thin film, transdermal, process development).
• Ability to understand technical aspects of drug formulation and process technology.
• Previous cGMP & related design record experience desired.
• Expert in design control processes including experience in Quality-By-Design (QbD).
• 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.
• Works well under pressure ensuring tasks and goals are met.
• Previous experience with LEAN and SIX SIGMA desired.

Responsibilities

• Leads and manages PDP process development, scale-up, tech. transfer and validation of formulations and manufacturing processes.
• Oversees packaging development for specialty drug delivery products in compliance with 21 CFR 211.
• Directs PDP team in experiments, data collection, analysis and reporting using statistical tools.
• Ensures design records support product development and ARx PDP requirements.
• Maintains records for formulas and processing methods; organizes technical information for efficiency.
• Communicates effectively with Quality, Operations, Marketing and Clients to achieve outcomes.
• Coordinates team tasks; conducts performance assessments and coaching.
• Leads deviation investigations and implements corrective and preventive actions.
• Mentors team members to increase capabilities and training.
• Contributes to IP strategy and strategic technology planning.
• Upholds safety and regulatory standards across all work activities.
• Leads and supervises direct reports; manages project tasks and timelines.
• Manages LEAN/SIX SIGMA initiatives.

Skills

Leadership

Project management

Statistical analysis

Qualitative analysis

Communication skills

Problem solving

Change control

Design of Experiments

LEAN

SIX SIGMA

Education

Bachelor’s degree in Science/Engineering/technical discipline

Graduate degree preferred

Job description

ARx Pharma seeks a senior professional to lead and manage the PDP process, including development, scale-up, tech transfer and validation of formulations and manufacturing processes for specialty drug delivery products in compliance with 21 CFR 211 and ARx PDP requirements.

The role requires extensive experience in drug formulation, cGMP, QbD and project leadership, with strong collaboration across Quality, Operations and Clients. Excellent problem-solving and communication skills are essential.