EPM Scientific is currently partnering with a client of the biotechnology industry - expanding in the German market building a drug substance manufacturing site.
KEY ACCOUNTIBILITIES:
Support of the transfer manager in the transfer product specific knowledge for the and testing of the products.
Analysis of errors and evaluation of quality-influenced process and plant structures.
Vote, planning and implementation of and activities of the process team.
Implementation of the technology transfer for the managed processes in the field of .
Responsibility for the implementation of the Ongoing Process (OPV).
Support of Run Phase in the project and consulting of project and operating management as an expert in process .
Support for the creation and revision of key documents such as process description and process risk analysis
Ensure the appropriate status of all manufacturing processes.
Support of the Working Area for internal projects
Creation and evaluation of deviations during process and cleaning valuations
Works with the conception and procurement of new plants up to the commissioning of new plants and technical optimization of inventories
REQUIREMENTS:
Self-initiative, self-focused operation
Reliability
Subsequent strengths in the (indirect) leadership of different teams of employees.
Quality and cost awareness
Critical judgment
Good cooperation and communication ability, team capacity
Conventional, enforcement, Flexibility, resilience
OTHER SKILLS , ABILITIES & EXPERIENCE:
Pharmaceuticals or comparable training, including specific training program.
Professional experience in parenteral manufacturing
Knowledge of parenteral freezing processes
Knowledge in and of pharmaceutical processes
Training and training measures in the field of GMPIT knowledge, or. Knowledge of automated quality systems ( regulations, deviation systems, systems, PLS)
Knowledge in project implementation
Knowledge of the industrial formulation of biotechnology
German and English in word and writing
If you are interested - reach out for more information!
