Process Manager (m/f/d) DSP

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.

As part of our group Process Science DSP, we are seeking a Process Manager (m/f/d). The Process Manager (m/f/d) will be in charge of the downstream processes of our customers’ APIs throughout the complete product lifecycle. This comprises the following key responsibilities:

Tasks and responsibilities

- Design and development of scalable downstream processes from bench to commercial scale for a wide range of biopharmaceuticals
- Transfer of customer downstream processes to the Rentschler process format.
- Design of late stage process optimization and process characterization / robustness studies by risk-based strategies in preparation of process validation at manufacturing scale

These responsibilities will be assumed by actively carrying out and managing the following tasks:

- Direct communication and representation towards our customers in “face-to-face meetings”, conference calls, etc.
- Consulting of our customers in subject matter-specific project strategy within the product lifecycle
- Ensure compliance with international technological and regulatory standards
- Responsible for compliance of timelines and milestones according to overall project plans
- Technical supervision of lab technicians and engineers in DSP development
- Scientific advice for manufacturing science and technology team (scale up to internal and external production sites, deviations, changes, process validation)
- Subject matter expert in an interdisciplinary and cross-functional team with colleagues from production, USP, quality control, QA/RA and innovation
- Compile and review protocols and reports in a timely manner
- Review relevant chapters of CMC dossiers (IND/IMPD and BLA/MAA)
- Participate in customer audits and authority inspections
- Participate in innovation and internal projects for driving progress of the group / company

What is important to us

- PhD or relevant experience in biotechnology, biochemistry or comparable scientific/technical field
- Several years of active experience in the field of DSP development preferably using scalable technologies in context of industrial pharmaceutical manufacturing
- Deep knowledge and understanding of chromatographic processes, filtration techniques, protein chemistry and analytical methods
- Knowledge of typical biopharmaceutical lifecycles and regulatory guidelines as well as experience in the topics of Quality-by-Design (QbD), process control strategies, Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) are beneficial
- Deep knowledge and experience with Design-of-Experiments (DoE), statistical modelling and corresponding software (JMP)
- Application-oriented basics in statistics (TOST test, p-value, trend & outlier analysis, etc)
- Hands-on experience with AI-tools, generation of automated workflows for data compilation, evaluation and reporting, and general prompting skills to accomplish complex tasks are beneficial
- Basic knowledge in upstream processing
- Basic knowledge in project management
- High level of initiative and excellent organizing ability
- Entrepreneurial mindset, economic and analytical thinking
- Strong and collaborative communication skills, team spirit, flexibility and outcome-oriented working
- Fluency in German and English

What you can look forward to

- Meaningful Work:  Become part of a company that makes a real difference for critically ill patients by developing and producing vital medications
- Inspiring Work Atmosphere:  Experience the joy of working in a collegial environment that promotes collaboration and team spirit on-site
- Individual Development Opportunities:  Access to personalized training programs
- Compensation:  Attractive salary and 13th-month salary
- Flexible Work Arrangements:  Flexible working hours, options for remote work, 30 vacation days, and special leave days
- Communal Breaks:  Cafeteria with vegetarian/vegan options
- Health : Corporate health management, company doctor, EGYM Wellpass
- Shared Experiences:  Team and company events
- Eco-friendly Mobility:  Leasing options for (e-)bikes, e-scooters
- Family-friendly Support:  In-house daycare center
- Employee Benefits:  Company pension plan, variety of employee discounts (corporate benefits), discounts on the job ticket, financial relocation support beyond a certain distance, free parking, comprehensive onboarding program