New Product Introduction Program Manager - Biologics Manufacturing

Overview

A distinguished company in biopharmaceutical manufacturing is recruiting a seasoned NPI Launch Site Lead dedicated to overseeing the integration of new biologic products into commercial manufacturing processes. This senior leadership role encompasses ownership of technology transfer, management of technical teams, and ensuring operational excellence at the manufacturing site.

Key Responsibilities

• Lead and nurture a diverse team of 7 to 9 engineers and scientists engaged in NPI initiatives.
• Manage the complete technology transfer lifecycle of drug product processes into manufacturing environments.
• Provide expert technical guidance for both new product introductions and commercial product maintenance, including troubleshooting, process optimization, handling deviations, conducting investigations, and implementing change controls.
• Ensure strict adherence to process validation protocols, monitoring procedures, and maintain Good Manufacturing Practice (GMP) compliance.
• Collaborate extensively with cross-functional teams such as Quality Assurance, Validation, Manufacturing Science & Technology, and international stakeholders.
• Drive the adoption of innovative technologies, new equipment installations, and continuous process enhancements.
• Utilize data analytics and statistical techniques to enhance operational performance and support informed decision-making.
• Maintain compliance with Environmental, Health, and Safety (EHS) standards as well as relevant regulatory requirements.

Qualifications and Skills

• Master of Science degree or equivalent in scientific or engineering disciplines.
• Robust background in biologics manufacturing, new product introduction, or process engineering fields.
• Demonstrated success in technology transfer and launching new products.
• Proven leadership experience managing technical teams.
• Comprehensive knowledge of GMP guidelines and regulatory frameworks.
• Excellent communication skills with strong stakeholder engagement capabilities.
• Analytical mindset with proficiency in statistical data analysis.

Why Join This Role?

• Opportunity to lead impactful new product launch projects with significant business influence.
• Engage in extensive leadership responsibilities and collaborate globally.
• Play a pivotal role in shaping manufacturing strategy and driving operational excellence.