Specialist Manufacturing Processes Bulk DP/Formulation (m/w/d)

Overview

Join to apply for the Specialist Manufacturing Processes Operations role at BioNTech SE.

Mainz, Germany | full time | Job ID: 8410

At the individualized neoantigen specific therapy facility, cancer therapeutics will be produced individually for each patient in order to meet their personal needs. The role of Specialist Manufacturing Processes supports the daily operations in production to enable smooth production. As support for the subject matter experts (SMEs), the role holder possesses in-depth process knowledge in the areas of DNA production, RNA production, lipoplexation, fill & finish, labeling, packaging and visual inspection. Tasks include root cause analysis and risk assessment for process deviations and the definition of corrective and preventive measures. The Specialist Manufacturing Processes further coordinates change control.

Your main responsibilities

• Support for subject matter experts (SMEs) regarding product and process knowledge for the production of individualized cancer therapy (DNA production, RNA production, lipoplexation, fill & finish, labeling, packaging and visual inspection) during the project phase
• Handling of deviations occurring during the production process
• Creation of area-specific documents (e.g., SOPs, working procedures, forms)
• Definition and implementation of corrective and preventive actions (CAPA management)
• Coordination of change procedures in production (Change Owner)

Your profile

• University degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
• 2 years of experience in manufacturing/production or relevant experience, ideally in a biotech or pharmaceutical company
• Good knowledge of EU GMP regulations
• General understanding of technical processes
• High carefulness and accuracy in the way of working, conscientiousness, and detail-orientation
• Refined colloquial and correspondence skills in English (B2) and in German (B2)

Benefits

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

How to apply

Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team at +49 (0) 6781 9855 211 (Monday-Friday from 12 PM to 4 PM CET).

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider HireRight. You will be informed accordingly by your Recruiter.