Advancing medicine to save lives. Together.
Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.
Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.
Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.
As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.
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 Process Science and Manufacturing 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 within our internal network and to external manufacturing sites
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
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
Fluency in English
Expertise in biotechnological processes, with an emphasis on and experience with commercial products
Experience in continued process verification (CPV)
Know-how in statistical concepts and tools
Knowledge of downstream processing is a plus
Process qualification/validation (PPQ) experience 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 Rentschler Academy
30 days of holiday
Flexible working hours, flexitime account and mobile working
Responsibility, initiative, further development
Team and company events
Company health management
Various employee discounts
Future-proof industry
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What We Do
Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, including advanced therapies, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with operations in Milford, MA, USA and Stevenage, UK. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability
