Director Technology Transfer

i-Pharm Consulting; Wilmington (DE); On-site; USD 162,000 - 198,000; Full time

Job summary

i-Pharm Consulting is seeking an experienced pharma Technical Leader to drive technology transfer into commercial manufacturing. You will lead cross-functional teams and ensure regulatory readiness for product introductions, with a strong focus on Oral Solid Dosage and related processes.

The role requires 10+ years in pharma, a solid background in cGMP, and demonstrated capability to manage complex, cross-site projects and stakeholder relationships. On-site work in the U.S. market.

Qualifications

• Bachelor's degree or higher in a related science/engineering field.
• 10+ years in pharma, including Tech Ops, MS&T, or NPI.
• Experience with drug product tech transfer and scale-up.

Responsibilities

• Lead technology transfer activities into commercial manufacturing operations.
• Drive development, registration, clinical, validation, and commercial campaigns.
• Provide technical leadership and ensure cGMP compliance and safety.
• Collaborate with QA, Validation, Regulatory, and Manufacturing teams.
• Develop PPQ strategies and support CPV programs.

Skills

Technical Leadership

Project Management

Cross-functional Collab

cGMP Compliance

Process Transfer

Stakeholder Management

Education

Bachelor's degree

Advanced degree preferred

Job description

SALARY: Starting from $180,000 USD + Bonus & LTI

Key Responsibilities:

Technical Leadership & Technology Transfer:

• Lead technology transfer activities from development organizations, partner facilities, or external manufacturing sites into commercial manufacturing operations.
• Demonstrated experience with Oral Solid Dosage (OSD) products is required; experience supporting injectable products is advantageous.
• Assess, select, and implement manufacturing process technologies, equipment, and methodologies to support successful product introduction.
• Develop, optimize, and monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
• Provide technical leadership for manufacturing operations, including troubleshooting complex process challenges, supporting investigations, and ensuring compliance with cGMP and safety standards.

Project & Stakeholder Management:

• Drive the successful and timely delivery of development, registration, clinical, stability, validation, and commercial manufacturing campaigns.
• Serve as a primary technical point of contact for internal and external stakeholders throughout product introduction and commercialization activities.
• Build and maintain strong collaborative relationships through proactive communication, issue resolution, and risk management.
• Evaluate stakeholder requirements and align project execution plans with manufacturing capabilities to achieve successful outcomes.

Team Leadership & Operational Strategy:

• Lead, mentor, and develop NPI professionals, promoting a culture of accountability, collaboration, and continuous learning.
• Partner with senior leadership to establish strategic objectives, improve NPI processes, and define measurable performance indicators.
• Ensure clear ownership, accountability, and effective coordination across cross-functional and matrixed project teams.
• Support continuous improvement initiatives that enhance operational efficiency and project execution.
• Collaborate with Manufacturing, Technical Operations, Quality, and Validation teams to develop and execute process performance qualification (PPQ) strategies.
• Support Continued Process Verification (CPV) programs and commercial launch activities.
• Act as a subject matter expert during regulatory inspections and audits, providing technical support to demonstrate manufacturing readiness and compliance.
• Contribute to regulatory submission support activities and inspection preparedness efforts.

Qualifications

• Bachelor's degree or higher in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Life Sciences, or a related scientific or engineering discipline.
• 10+ years of experience within the pharmaceutical industry, including Technical Operations, Manufacturing Sciences & Technology (MS&T), Research & Development, Process Development, or New Product Introduction.
• Significant experience supporting drug product technology transfer, process scale-up, validation, and commercial manufacturing.

Technical Expertise

• Strong understanding of drug product development, process transfer, validation, and commercial manufacturing operations.
• Deep knowledge of pharmaceutical manufacturing processes, particularly Oral Solid Dosage (OSD) products.

Regulatory & Quality Knowledge

• Working knowledge of global regulatory expectations, including FDA, EMA, ICH guidelines, and current Good Manufacturing Practices (cGMP).
• Familiarity with validation requirements, continued process verification, and pharmaceutical quality systems.