Biotechnologist - Process Management Upstream Development (m/f/d)

Beschreibung

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1100 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!

As part of our group Process Science, we are seeking a Process Manager USP (m/w/d). The Process manager will oversee the upstream processes of our customers' APIs throughout the complete product life cycle. This comprises the following key responsibilities which will be fulfilled in close collaboration with our Manufacturing Science and Technology departments:

• Design of robust, scalable and economic upstream processes for a wide range of biopharmaceuticals in line with clinical and commercial timelines and overall business plans
• Process scale up and transfer to our internal and external manufacturing sites
• Design of late stage development activities and process characterization studies in preparation of process qualification and validation at manufacturing scale
• Assessment and implementation of new process technologies

• Direct communication and representation towards our customers in face-to-face meetings and conference calls
• Interdisciplinary and cross-functional interaction with colleagues from associated departments
• Troubleshooting and process optimization at bench and manufacturing scale
• Participation in deviation, out-of-specification and change management
• Compilation and review of risk assessments, protocols and reports
• Ensuring compliance with international technological and regulatory standards
• Review of relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
• Participation in customer audits and authority inspections
• Involvement in process optimization and innovation projects

• PhD or relevant experience in biotechnology, biochemistry or comparable scientific/technical field
• Several years of active experience in the field of upstream processing using scalable technologies in the context of biopharmaceutical manufacturing
• Strong and motivating communication skills, team spirit and flexibility
• High level of initiative and excellent organizing skills
• Entrepreneurial mindset, economic and analytical thinking
• Fluent in German and English

• Expertise in cell culture processes, cell separation technologies and respective analytical methods
• Experience in process qualification/validation (PPQ) and/or continued process verification (CPV)
• Knowhow in statistical concepts and tools

• Work in a company that offers real value and manufactures medicines for critically ill patients
• Contagious joy in the job as well as a collegial working environment
• Access to exclusive, personalised training through the Global Rentschler Academy
• 30 days of holiday
• Flexible working hours and mobile working
• Responsibility, initiative, further development
• Company health management and pension scheme
• Company child-care centre
• Future-proof industry