Mainz, Germany | full time | Job ID: 9382
The global Manufacturing Manager DSP (Downstream Processing) within the global MS&T (Manufacturing Science & Technology) Drug Substance team is a highly skilled expert in downstream processing technologies. This role plays a critical part in ensuring the successful development, implementation, and optimization of purification processes across the manufacturing lifecycle. You will contribute to the manufacturing process ownership by providing technical expertise in chromatography, depth filtration, tangential flow filtration, virus inactivation, and virus filtration. The role requires close collaboration with internal departments, contract manufacturers, and manufacturing network partners to achieve operational excellence and ensure product quality.
Responsibilities:
o Facilitate the successful transition of manufacturing processes during product launches and technology transfers between commercial manufacturing sites.
o Provide technical guidance for DSP-related activities throughout the manufacturing lifecycle.
o Support the transition of upstream processes into downstream operations during launch activities and tech transfers.
o Collaborate with CMC teams to implement procedures from scale-down models into at-scale manufacturing activities.
o Ensure alignment of DSP processes across sites and partners to maintain consistency and quality.
o Serve as the DSP interface to internal departments such as Quality Assurance (QA), Engineering, Regulatory Affairs (RegAff), and CMC.
o Management of external partners, including contract manufacturers and manufacturing network collaborators.
o Responsible for covering topics within the internal DS Network (multiple BNT sites).
o Contribute to regulatory filing activities, including initial submissions and updates, by reviewing and aligning dossier content in the field of DSP expertise.
o Ensure compliance with regulatory requirements and support audits as needed.
o Gather performance and capability data from manufacturing sites to identify opportunities for process harmonization and improvement.
o Drive cross-site lessons learned and implement best practices to enhance DSP operations.
o Lead cross-site investigations to identify and resolve process issues related to DSP.
Qualifications:
* Advanced degree (MSc or PhD) in Biotechnology, Biochemistry, Chemical Engineering, or a related field.
* Extensive experience in downstream processing technologies, including chromatography, filtration, and virus inactivation.
* Proven track record in manufacturing process development, optimization, and lifecycle management.
* Experience in tech transfer and launch activities within a biopharmaceutical or biotechnology environment.
* Deep technical knowledge of DSP operations and equipment.
* Strong problem-solving and analytical skills, with the ability to lead investigations and implement solutions.
* Excellent communication and collaboration skills to work effectively across internal teams and external partners.
* Familiarity with regulatory requirements and filing processes.
Your Benefits:
It's our priority to support you:
* 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
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 9382 (please always specify if you have any questions)
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 BioNTech-Recruiter.