Manager CMC Lipid and Raw Material (Mainz, RP, DE, 55116) at BioNTech

Mainz, Germany   |   full time   |   Job ID: 9707 

In this role you will be the CMC representative of raw materials (e.g. starting materials, lipids, other excipients and buffer solutions) of BioNTech’s mRNA product pipeline. You will ensure the phase-appropriate GMP quality as well as coordinate the therefore required material development work. This includes also new, customized materials that need to be escorted from preclinical R&D batches to commercial production at CDMOs.

Your main responsibilities are:

• Supervision of CDMOs of lipids and raw materials regarding process and analytical development and validation, ongoing material supply, process changes, and upscaling
• Compilation of technical and quality requirements of the respective materials and communication to the suppliers
• Evaluation of risks associated with raw materials to the product quality and safety and development of material control strategy (e.g. identification of critical material attributes (CMA) and definition of specifications)
• Lead evaluation and selection process for new/alternative material suppliers in close collaboration with procurement, business development, and legal & intellectual property
• Lead or support the compilation of quality- and regulatory-relevant documents (e.g. change controls, risk analyses, and CMC sections of clinical dossiers)
• Identification of material needs (quantity & quality) in close collaboration with CMC Project Management, Supply Chain, GMP Manufacturing, Procurement and Quality

What you have to offer:

• PhD in chemistry, pharmacy, or material science, and several years of professional experience in an international pharmaceutical environment
• Profound knowledge of organic chemistry and material-related analytics (e.g. HPLC, mass spectrometry). Experience in mRNA manufacturing, drug delivery, or nanoparticulate formulations is considered a plus
• Knowledge of GMP regulations and experience in working in a CMC development function, ideally with focus on material qualification or process validation. Familiarity with regulatory filings for starting materials, novel excipients or APIs (IND/IMPD, BLA/MAA) is beneficial
• Solution-oriented thinking and the ability to make strategic decisions in a highly dynamic environment
• Ability to work with cross-functional interface partners as well as a structured and organized way of working
• Excellent negotiation skills, assertiveness, and ability to communicate with internal and external stakeholders clearly and concisely. Fluency in English, German is a plus

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 9707 (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.