USP Cell Culture Plant Expert (femle/male)(Experts Team)

The USP Expert’s day-to-day responsibilities include analyzing the status of propagation, inoculum expansion, and cell culture processes, as well as close collaboration with expert teams and Production.

The role involves analysis of process data and campaign trends, supporting deviation investigations, and defining corrective and preventive actions (CAPA). The USP Expert actively participates in change controls, risk assessments, and technology trials within the manufacturing area.

A significant portion of the role is dedicated to preparing, reviewing, and maintaining manufacturing documentation, procedures, and work instructions, as well as delivering trainings.

The position also supports process validation, technology transfers, and process optimizations, and presents technical topics during audits and inspections.

On a daily basis, the USP Expert collaborates with Manufacturing, Quality, Engineering, Supply Chain, and other supporting functions.

Your responsibilities

• Supervision and technical ownership of mammalian cell culture manufacturing processes in accordance with current Good Manufacturing Practice and approved documentation

• Active participation in the manufacturing of biotechnological medicinal products and continuous process monitoring

• Initiation and implementation of manufacturing process improvements and optimization activities

• Participation in technology transfer, process validation and qualification of equipment and systems

• Preparation, review and management of manufacturing and regulatory documentation

• Acting as a subject matter expert in deviation investigations, change control, risk assessments and corrective and preventive actions

• Development of standard operating procedures and delivery of technical trainings

• Technical support of media and supplement preparation processes, including single use and stainless steel technologies

• Cooperation with manufacturing, engineering, quality and project teams

• Support during internal, external and customer audits and inspections

Our expectations

• Higher education in a relevant scientific or technical field

• At least five years of experience in biopharmaceutical manufacturing or the pharmaceutical industry

• Experience with mammalian cell culture processes at production scale

• Knowledge of upstream processing, including cell banking, cell expansion and production culture

• Experience in process validation, equipment and system qualification and technology transfer

• Practical knowledge of single use and stainless steel manufacturing technologies

• Experience in preparation and processing of manufacturing documentation

• Good knowledge of regulatory requirements for biological medicinal products

• Very good command of written and spoken English

• Strong organizational skills, independent working style and ability to collaborate in cross functional teams

We offer

• Employment in a fast growing biopharmaceutical organization

• Participation in advanced manufacturing processes for innovative biological medicinal products

• Real influence on process development, optimization and implementation of new technologies

• Stable employment based on an employment contract

• Competitive compensation package and employee benefits

• Opportunities for continuous professional development and participation in specialized trainings

• Work in a team of experienced experts within a modern manufacturing environment