Sr. Scientist, Engineering

Job Description

As part of our Company’s 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. 

This position may require travel up to 25%. Must be able to travel for this position. 

Accountabilities and Responsibilities for this position include but are not limited to the following: 

• Designs and executes studies to develop and characterize sterile drug product processes, including the establishment of the commercial integrated control strategy.

• Develops and transfers robust processes to the Drug Product (DP) commercial manufacturing site.

• Builds strategy and technical framework for process validation at commercial sites

• Manages DP activities for in line and pipeline programs, including completion of regulatory filings and product life-cycle management.

• Ensures appropriate experimental design principles including DOE are used where applicable.

• Ensures fit-for-purpose scale-down models are developed and employed.

• Authors technical protocols for studies, ensures appropriate design of experiments and sample size selection. Ensures acceptance criteria for study outcomes are pre-defined (e.g. performance parameter range, analytical result range etc.).

• Responsible for sample submission and tracking. Employs statistical tools and methods to analyze results.

• Authors technical reports that can be used as source documentation for regulatory filing.

• Ensures technical information is clearly understood and integrated into decision making.

• Authors or performs second-person review (SPR) for high-quality CMC sections for regulatory submissions.

• Establishes and validates platform engineering and scientific models for sterile product and process commercialization.

• Ensures commercialization programs meet requirements related to science, quality, reliability, schedule, and cost.

• Applies technical and functional knowledge to design experiments that contribute to overall direction of department/discipline. Uses advanced experience gained on scientific/technical issues to guide others to address non-routine and/or difficult issues.

• Serves on cross functional teams to support strategic initiatives.

• Drives continuous and phase-appropriate process optimization towards standardized platforms for liquid, lyophilized, and combination products presentations.

• Establishes and fosters a culture of high performance, out of the box thinking, innovation and learning, empowerment, diversity, and inclusion. 

Minimum Education Requirement and Experience: 

• Bachelor of Science (B.S.) in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with five (5) years of relevant experience OR

• Master of Science (M.S.) degree in chemical engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or rela