|at ( view profile)|
|Date Posted||July 3, 2019|
|Address||726 Heartland Trail|
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Senior Process Engineer
Catalent is looking to recruit a Senior Process Engineer to join a growing team in Madison, WI.
The Senior Process Engineer will lead the tech transfer, scale up and process documentation required to transfer Phase I-III/Commercial processes from Process Development into Manufacturing. The Senior Process Engineer will be the subject matter expert for the production process activities including scale-up and technical process knowledge for specific programs. They will also manage specific client requests, attend client meetings and understands uniqueness of each process. The Senior Process Engineer will 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.
***Please note that relocation assistance is available for the right candidate***
- Recommends process scale-up of biological processes, leads gap analyses to identify key process parameters and equipment needs to facilitate process transfer into manufacturing.
- Directs the development of a strong and robust Technology Transfer process (both internal and external) to support both clinical and late phase production.
- Manages 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.
- Champions 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 5 years of biopharmaceutical process development and manufacturing experience
- MS in Biotechnology, or related field with at least 8 years of biopharmaceutical process development and manufacturing experience
- B.S/B.A. in Biotechnology, or related field with at least 10 years of biopharmaceutical process development and manufacturing experience
- Associates Degree/Certificate/Diploma in laboratory science with minimum of 15 years of biopharmaceutical process development and manufacturing experience
Catalent’s standard leadership competencies that are used to interview and for Performance & Development:
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
- Potential for career growth within an expanding team
- Defined career path and annual performance review & feedback process
- Cross functional exposure to other areas of Catalent
- Medical, Dental, Vision, and 401K are all offered from day one of employment
- 19 days of paid time off annually + 7 paid holidays