Sr. Scientist, Engineering

Senior Scientist

As part of our manufacturing division, the Sterile Drug Product Commercialization (SDPC) group provides the technical process leadership and laboratory capabilities for late-stage and commercial drug product processes for vaccines, biologics, and sterile pharmaceutical products. The SDPC team is based out of West Point, PA, USA, with a presence in Carlow, Ireland, supporting Irish and European Sterile Drug Product manufacturing sites.

The SDPC group is the division's leader in sterile product and process development, responsible for commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group is responsible for establishing the science, engineering and knowledge required for today's innovative and accelerated commercialization of novel vaccines, biologics, pharmaceutical products, and combination products.

The SDPC group supports the growing pipeline of diverse products and evolving technologies.

We are seeking a Senior Scientist to be the lead drug product scientist responsible for establishing and executing commercial process development studies for targeted biologics pipeline and inline programs. The Senior Scientist will develop and transfer robust and scalable manufacturing processes while minimizing time to launch and implement process improvements to reduce cost structure and enhance process robustness.

Responsibilities:

• Design and execute studies to develop and characterize sterile drug product processes, including the establishment of the commercial integrated control strategy.
• Develop and transfer robust processes to the Drug Product (DP) commercial manufacturing site.
• Build strategy and technical framework for process validation at commercial sites.
• Manage DP activities for inline and pipeline programs, including completion of regulatory filings and product life-cycle management.
• Ensure appropriate experimental design principles, including DOE, are used where applicable.
• Ensure fit-for-purpose scale-down models are developed and employed.
• Author technical protocols for studies, ensuring appropriate design of experiments and sample size selection.
• Ensure acceptance criteria for study outcomes are pre-defined (e.g., performance parameter range, analytical result range, etc.).
• Responsible for sample submission and tracking, employing statistical tools and methods to analyze results.
• Author technical reports that can be used as source documentation for regulatory filing.
• Ensure technical information is clearly understood and integrated into decision-making.
• Author or perform second-person review (SPR) for high-quality CMC sections for regulatory submissions.
• Establish and validate platform engineering and scientific models for sterile product and process commercialization.
• Ensure commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.
• Apply technical and functional knowledge to design experiments that contribute to the overall direction of the department/discipline.
• Serve on cross-functional teams to support strategic initiatives.
• Drive continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination products presentations.
• Establish and foster a culture of high performance, out-of-the-box thinking, innovation and learning, empowerment, diversity, and inclusion.

Qualifications:

Required:

• Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with six (6) years of hands-on experience in laboratory DP Process development, scale-up, and technology transfer of sterile drug product manufacturing process experience OR MS with four years, OR Ph.D. with no industry experience.
• Excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.
• Experience in the process development and manufacturing of large biological molecules, with an understanding of protein attributes.

Preferred:

• Experience in process optimization, scale-up, and technology transfer of sterile biologics products to pilot/commercial scale.
• Working knowledge of current Good Manufacturing Practices (cGMPs) for manufacturing of sterile dosage forms and current ICH Quality norms, as applied in Manufacturing Science and Technology or Technical Operations.
• Experience with utilization of QbD principles to process development and life cycle management.
• Experience in authoring and reviewing CMC regulatory documentation.
• Project management and activities management skills (dashboards, activity trackers).
• Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scale.
• Competency in problem-solving skills and technical writing.

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