Director, Engineering - Drug Product Commercialization

Job Description

Job Description: Director, Center of Excellence for Sterile Drug Product Commercialization

Overview

We are seeking a dynamic and experienced leader for the role of Director within our Center of Excellence (CoE) for Sterile Drug Product Commercialization.  Sterile Drug Product Commercialization is the Company's Manufacturing Division business unit responsible for late-stage development of vaccines, biologics and sterile pharmaceutical drug products.  Sterile Drug Product Commercialization also provides drug product process development and process characterization laboratory services for inline products.

This position will be pivotal in overseeing core drug product technologies, building our pipeline platforms and standard work systems, establishing innovative solutions for our sterile processes and providing oversight to our inline product support laboratory. The CoE will drive innovation and operational excellence in the development and commercialization of sterile drug products through the use of core and innovative technologies.

About Us

Our company, a global biopharmaceutical leader, operates in the United States, Canada, Puerto Rico, and across Europe, the Middle East, Africa, Latin America, and Asia Pacific. With a diverse portfolio that includes prescription medicines, oncology, vaccines, and animal health products, we are committed to developing and delivering innovative solutions that save and improve lives. Our workforce of 69,000 employees in over 140 countries is dedicated to research and development, with a proud history of 125 years of service to humanity.

Key Responsibilities

As the Director of the Center of Excellence, you will:

• Lead Technical Excellence: Oversee the design, development, and commercialization of sterile liquid and lyophilized drug products, ensuring robust validation and technology transfer processes.
• Team Management: Manage a team of scientists and engineers, fostering talent development, mentorship, and strategic guidance to enhance technical capabilities.
• Project Oversight: Ensure that commercialization programs meet scientific, quality, reliability, schedule, and cost requirements. Monitor performance and recommend adjustments as necessary.
• Process Optimization: Drive continuous improvement initiatives and implement standardized platforms for liquid, lyophilized, and combination product presentations.
• Innovation and Collaboration: Actively seek cutting-edge technologies in manufacturing and testing, and develop collaborations with internal and external partners.
• Resource Management: Optimize resource allocation across projects to achieve business objectives and support due diligence and business development opportunities.
• Culture Building: Establish a high-performance culture that promotes innovation, diversity, and inclusion within the team.

Qualifications

Education

• Doctorate in Applied Sciences, Engineering, or a related discipline with 6+ years of relevant experience in vaccines, biologics, or advanced therapies.
• Master’s degree with 8+ years of relevant experience.
• Bachelor’s degree with 10+ years of relevant experience.

Preferred Expertise

• Proven experience in the manufacturing of sterile drug products at pilot or commercial scale.
• Strong knowledge of cGMPs and ICH Quality norms in Manufacturing Science and Technology.
• Familiarity with Digitalization, Industry 4.0, and Data Analytics applications.
• Experience applying Quality by Design (QbD) principles in process development and lifecycle management.
• Experience with implementing platforms and standard work in CMC commercialization, technical operations or manufacturing
• Experience with process modeling, and development of scale-up and scale-down models
• Proficiency in Design of Experiments (DoE) and statistical data analysis.
• Experience in authoring and reviewing CMC regulatory documentation.
• Financial acumen with experience in resource forecasting and budgeting.

Travel Requirements

• Willingness to travel approximately 10% of the time.

Join Us

We are looking for innovative and adaptable leaders who are passionate about making a significant impact in the biopharmaceutical industry. If you are ready to bring your disruptive thinking and collaborative spirit to our organization, we invite you to apply and help us continue our mission of Inventing for Life and Impacting Lives while Inspiring Your Career Growth.

This position is specifically focused on building a Center of Excellence for Sterile Drug Product Commercialization in Penns