This position will be part of the Manufacturing Sciences group tasked with supporting the transfer, execution and monitoring of mammalian cell culture and purification processes in our manufacturing suites.
The Process Engineer will support the site’s strategic plan by working with Consultants, Manufacturing and Quality personnel to manage the deliverables required to prepare the Madison, WI site for early Phase and Phase III/Commercial manufacturing.
The Process Engineer will develop the tech transfer, scale up and process documentation required to transfer Phase I-III/Commercial processes from Process Development into Manufacturing.
This person will be the subject matter expert for the production process activities including scale-up and technical process knowledge for specific programs.
The Process Engineer will also support specific client requests, attend client meetings and understands uniqueness of each process. Support the Program Managers and Commercial Readiness Team and drive the closure of process gaps. This position will also play a significant role in the technical support of the construction of an additional GMP operations suite.
In concert with Catalent’s Patient First philosophy, this role is critical to the safe and on-time delivery of our clients products to patients by providing guidance and oversight of well-defined and documented manufacturing processes.
- Evaluates process scale-up of biological processes, performs gap analyses to identify key process parameters and equipment needs to facilitate process transfer into manufacturing.
- Supports the development of a strong and robust Technology Transfer process (both internal and external) to support both clinical and late phase production.
- Supports the authoring of Process Descriptions and Batch Records, support equipment, commissioning, process training, and validation activities.
- Leads facility fit activities for existing and future internally and externally transferred processes.
- Leads the process development component of the Commercial Readiness Team to ensure the facility and its processes are ready for Phase III / Commercial production.
- Identifies best practices and drives adoption into the manufacturing group to improve clinical and commercial production processes
- Ph.D. in Biotechnology, or related field with at least 3 years of biopharmaceutical process development and manufacturing experience
- MS in Biotechnology, or related field with at least 4 years of biopharmaceutical process development and manufacturing experience
- B.S/B.A. in Biotechnology, or related field with at least 7 years of biopharmaceutical process development and manufacturing experience
- Associates Degree/Certificate/Diploma in laboratory science with minimum of 10 years of biopharmaceutical process development and manufacturing experience
- 3+ years of relevant work experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities