Biotechnologist - Process Management Manufacturing, USP (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!

• 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 within our internal network and to external manufacturing sites
• Design of late-stage development activities and process characterization studies in support of process qualification and validation at manufacturing scale
• Definition of control strategies for commercial manufacturing
• Setup and performance of continued process verification

• Direct communication and representation towards customers in face-to-face meetings and conference calls
• Interdisciplinary and cross-functional interaction with colleagues from associated departments
• Troubleshooting and process optimization at manufacturing scale
• Participation in deviations, out-of-specifications, and change management
• Ownership and review of process descriptions, 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
• Continuously striving for improvement and optimization in all areas of work

• University degree in biotechnology, pharmaceutical engineering, bioprocess engineering, chemical engineering, or comparable scientific/technical field
• Multiple years of experience in upstream processing using scalable technologies in the context of biopharmaceutical manufacturing
• Strong and motivating communication skills, team spirit, and flexibility
• High level of initiative, personal responsibility, and excellent organizational skills
• Entrepreneurial mindset, economic and analytical thinking
• Good fluency in English

• Expertise in biotechnological processes, with an emphasis on and experience with commercial products
• Experience in process qualification/validation (PPQ)
• Experience in continued process verification (CPV)
• Know-how in statistical concepts and tools
• Knowledge of downstream processing is a plus

• 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, flexitime account and mobile working
• Responsibility, initiative, further development
• Company health management and pension scheme
• Company child-care centre
• Future-proof industry