Specialist Manufacturing Processes - Bulk Drug Product/Formulation | Biotechnologe (m/w/d)
Unknown Employer
Job Summary
This role supports the daily operations of manufacturing individualized neoantigen specific cancer therapies in a dynamic biotech environment in Mainz. The specialist acts as a key support function for Subject Matter Experts (SMEs), leveraging deep process knowledge in lipoplexation, filtration, and integrity testing, specifically within Single Use Systems (SUS). Day-to-day tasks involve rigorous GMP compliance, including initiating and processing deviations, performing root cause analysis, defining corrective and preventive actions (CAPA management), and coordinating change control. Furthermore, the specialist creates and updates critical documentation like SOPs, forms, and Master Batch Records (MBRs), and supports the setup of digital production systems (eQMS, SAP, MES). This position offers a high degree of independence, the opportunity to lead or participate in OPEX/CAPEX projects, and the chance to contribute directly to life-saving personalized medicine.
Required Skills
Education
Relevant scientific or technical vocational training (e.g., BTA, CTA, PTA) or a relevant higher academic degree (e.g., Bachelor Professional, State-certified technical engineer, B.Sc., M.Sc., Diploma, PhD)
Experience
- Several years of relevant professional experience (typically >3 years), ideally in aseptic manufacturing/production or a related field
- Experience in a biotech or pharmaceutical company preferred
- Experience with digital manufacturing solutions (e.g., LIMS, PCS, MES, ERP) and eQMS is beneficial
Languages
Additional
- Solid GMP knowledge (e.g., EU GMP Guidelines, Annex 1, Guidelines for ATMPs, FDA cGMP Regulations) is advantageous.