Senior Process Engineer - Manufacturing Science & Technology, Downstream Technology Transfer

Senior Process Engineer - Manufacturing Sciences & Technology, Downstream

Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent Biologics is a fast growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.  The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.  Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Manufacturing Sciences and Technology (MS&T) department’s primary function is to serve as an agile technical services team to support process & technology transfer (e.g., mAbs, fusion proteins, enzymes, mRNA, new modalities, etc.), process readiness and execution support related to documentation, equipment, consumables and materials, and technical writing.  The MS&T organization supports the Madison facility as well as the Catalent Biologic’s network through client- facing support, on-the-floor or on-call technical coverage, as well as continuous improvement and site strategy projects.

The Technology Transfer groups (Upstream and Downstream) are the technical liaisons between Process Development (internal or external) and at-scale GMP manufacturing relating to process transfer. This function includes drafting and supporting required batch documentation (i.e., gap assessments, reports, batch records, product impact), as well as process modeling and facility fit including initial bill-of-material development.

This role will provide on-call and on-the-floor technical support to manufacturing. The SME will be responsible for the drafting and review of documentation, compilation, and assessment of process data,  and providing technical input for deviation investigations, change controls, and CAPAs. This position will be client-facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.

This is a full-time role working Days; Monday – Friday 8am-5pm

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Support technology transfer of processes into manufacturing for both internally and externally developed processes.
• Oversee technical support of Manufacturing, including the technology transfer between external clients or Process Development and Manufacturing.
• Work alongside a group of engineers, scientists, and other colleagues to drive the facility fit and technical transfer of biologic processes.
• Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.
• Works closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.
• Leads and/or supports the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
• Evaluates existing processes and identifies process or equipment improvements to advance efficiency, consistency, and competitiveness within the market.
• Authors and reviews documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications and summary reports.
• Acts as the lead for technical support of risk assessments, gap analysis, deviations, ch