Upstream Biological Process, Lead Scientist

• Providing hands-on scientific and technical leadership in process insourcing, technology transfer, scale-up, and validation activities, ensuring robust, scalable, and compliant biopharmaceutical manufacturing processes.
• Coordinating upstream process development, optimization, and industrialization activities with internal R&D teams and external CMOs.
• Leading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance, and supply reliability.
• Assessing and interpreting complex scientific data to support decision-making, risk mitigation, resource allocation, and program strategy.
• Applying and promoting Quality by Design (QbD) principles and contributing to process characterization, control strategies, and validation plans.
• Supporting regulatory submissions (MAA, NDA, BLA, JNDA) and representing CMC process-related topics during interactions with health authorities.
• Designing, executing, and evaluating pilot-scale studies to support process development, optimization, scale-up, and technology transfer activities.
• Collaborating with Production, Quality, Engineering, and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ), and commercial process implementation.
• Supporting the development of GMP documentation, including batch records, risk assessments, validation protocols, and technical reports.
• Providing technical expertise for investigations, process deviations, change controls, and CAPAs, ensuring effective resolution and continuous process improvement.
• Delivering theoretical and practical training to Manufacturing personnel to ensure compliant and efficient execution of commercial production processes.

• MSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline.
• At least 10 years of experience in biopharmaceutical drug substance process development, with a proven track record of leadership in complex biologics CMC programs.
• Strong scientific background in biologics manufacturing and bioprocess development.
• Deep expertise in upstream process development and manufacturing, including mammalian cell culture (preferably CHO), single-use bioreactors, centrifugation, and depth filtration.
• Proven experience in process optimization, scale-up/down activities, technology transfer, and industrialization of biotechnological products.
• Solid knowledge of GMP requirements and global regulatory frameworks, including FDA, EMA, ICH, and CMC guidelines.
• Experience supporting regulatory submissions and managing manufacturing processes in FDA- and EMA/AIFA-approved facilities.
• Demonstrated ability to manage CDMO partnerships and external development activities.
• Strong understanding of product lifecycle management and commercialization strategies for biologics.
• Good knowledge of English (written and spoken).

The minimum salary for this role is € 62.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. 

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. 

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.