|Date Posted||February 10, 2021|
|Address||726 Heartland Trail, Suite 100|
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
I. Position Overview:
The Upstream Process Development team is responsible for the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures that can be successfully transferred to cGMP manufacturing to generate therapeutic proteins for human clinical trials. The unit operations, process parameters, and process information to be developed, executed, and transferred include, but are not limited to, seed train scale-up and production bioreactor inoculation specifications and setpoints, specific process parameter monitoring and data collection requirements, media and feeding strategies, and harvest criteria. The process development experiments involved with this research range from high-throughput, Design of Experiment (DoE) formats for clone screening and process optimization to pilot-scale Single Use Bioreactor (SUB) toxicology or engineering non-GMP runs to support cGMP manufacturing. To support this research, the team members also contribute to a variety of lab support areas including equipment maintenance, raw materials management, and investigation support; the project experiment designs and results are routinely communicated with external clients and internal functional areas to ensure the quality of the final process.
The person in this position will accurately, timely, and safely perform a variety of laboratory procedures in Upstream Process Development that support external client projects and internal technology development work by primarily focusing on the preparation of general lab solutions including cell culture media according to Batch Production Record (BPR) specifications. This person will also be performing routine, essential lab support assignments including equipment maintenance and cleaning, lab material stocking, general lab cleaning, and 5S organization. This work will involve applying technical knowledge in the use of standard upstream laboratory equipment and procedures such as incubators, biosafety cabinets, and culture sample analytics.
II. Specific Duties, Activities, and Responsibilities:
- Lab work:
- Execute laboratory work plan according to the schedule developed by the supervisor or senior team member. Also participates in assigned improvement projects when needed.
- Prepare general lab solutions including cell culture media according to Batch Production Record (BPR) specifications.
- Maintain and clean lab equipment including water baths, incubators, and biosafety cabinets; also wash bioreactors, glassware, plasticware, and carboys including autoclaving. Manage laboratory waste including trash, recyclables and biohazards including autoclaving.
- Assist with the ordering of consumables and restock general lab areas and satellite areas; work with the materials management team on stock room utilization.
- Maintain lab organization and 5S standards in the development lab; execute and document 5S audits of laboratory space and update areas as needed or requested. Also, file paperwork and work orders.
- Technical review:
- Perform parallel review of laboratory documentation including data verification when needed.
- Other duties as assigned.
III. Typical Position Requirements:
Education and Experience:
- High School Diploma with 5+ years of related experience.
- Associate’s degree in chemistry or closely related physical science with no related experience.
- Bachelor's degree in any non STEM discipline.