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i-Pharm Consulting

Director Technology Transfer

Career Insights for Director of Manufacturing

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What they do

A Director of Manufacturing oversees management of all areas of manufacturing to produce products and direct activities so that approved products are manufactured on schedule and within quality standards and cost objectives.

$177,199 / year median in Delaware

+6% projected growth

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Job Description

Director Technology Transfer at i-Pharm Consulting Director Technology Transfer at i-Pharm Consulting in Rockland, Delaware Posted in about 22 hours ago.

Type:

full-time

TITLE:

Director Technology Transfer

LOCATION
Wilmington, DE 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.

Validation & Commercialization Support:

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.