Post by AveThera

We’re Hiring: Technical Expert – Drug Substance (DS) 📍 Hennigsdorf, Germany | 🕒 Full-time 💼 Technical Operations / Manufacturing About AveThera AveThera is a next-generation biotech startup focused on transforming biologics manufacturing across Drug Substance (DS), Drug Product (DP), packaging, Quality Control (QC), and late-stage development. Our advanced facility integrates USP, DSP, and DPD (fill & finish) capabilities, supported by automated warehouse and supply chain operations and strict adherence to EU GMP, FDA, and EMA standards. Through automation, real-time data traceability, and intelligent process control, AveThera accelerates both clinical and commercial biologics production. What You’ll Do Lead the design and implementation of upstream and downstream DS processes Collaborate on facility build-out, equipment selection, and process commissioning Develop scalable cell culture and purification processes for biosimilars, including fed-batch, perfusion, and continuous processing Integrate automation systems and digital tools to enhance process control and efficiency Apply AI and machine learning to optimize process development and ensure robust data traceability Author and review GMP documentation and tech transfer packages Support regulatory filings and ensure EU GMP & FDA compliance Troubleshoot and optimize processes during scale-up and validation What You Bring MSc or PhD in Biotechnology, Biochemistry, or Chemical Engineering 8+ years in DS process development and biologics manufacturing Proven experience in facility startup and tech transfer Deep knowledge of bioreactor systems, Fed-Batch & perfusion process, chromatography, filtration, and advanced process technologies Experience with automation platforms and digital manufacturing tools Familiarity with AI/ML applications in bioprocessing and data integrity Fluent in English; German is a plus 📩 Interested candidates are invited to send their CV and cover letter to [email protected]