Process Manager, Upstream MSAT

Process Manager, Upstream MSAT

Rentschler Biopharma – Advancing medicine to save lives. Together. 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, we combine experts, expertise and years of experience to develop best‑in‑class solutions – together with our clients.

• Independent planning and design of demanding function‑related tasks in customer projects, with pronounced interface management and complexity as a specialist/process expert
• Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives
• Independent decision‑making in changing processes and action patterns
• Direct communication and representation to our customers in face‑to‑face meetings and telephone conferences for your own project section. This may include management of meetings
• Advising our customers on the specialist project strategy over the product life cycle
• Design, support and development of scalable upstream/downstream/analytical processes for a broad range of biopharmaceuticals to include definition of required control strategies
• Transfer of customer processes (upstream/downstream/analytics) to internal and external production sites through execution of the New Product Introduction (NPI) process
• Ensure compliance with international technological and regulatory standards
• Responsible for meeting timelines and milestones according to the overall project plan to include management of resources to accomplish objectives
• Responsibilities may include supervision/management direct staff reports. Leadership and staff development/training would be in scope.
• Collaboration as a technical expert in an interdisciplinary and cross‑functional project team
• Timely creation and review of protocols and reports
• Review of relevant chapters in CMC dossiers (IND/ IMPD and BLA/ MAA).
• Participation in customer audits and inspections by authorities
• Supporting the quotation process in collaboration with Business Development
• Onboarding and orientation of new employees
• Collaboration in innovation and internal projects to further develop and strengthen the department/company

Years of Experience (one of the following):

• A university degree in STEM and 8+ years of related experience
• A master’s degree in STEM and 5+ years
• A PhD in STEM and 3+ years of experience

• Expertise in Single Use Bioreactors and related process equipment, inoculum scale‑up, large scale mammalian cell culture, Perfusion/continuous processing, Harvest processing to include depth filtration and centrifugation, scale up, and associated In Process Analytical (IPA) methods. A familiarity with process control systems is essential
• Experience in GMP guidance, process performance qualification/validation (PPQ) and continued process verification (CPV)/Process monitoring
• Advanced ability with Microsoft Office (Word, Excel, Project, Visio, and PowerPoint), and Statistical analysis packages for data management and presentation
• Technical writing for memoranda, reports, protocols and similar documents

• The candidate should be self‑motivated, accountable, inquisitive, and have excellent organization and communication skills
• High level of initiative with an entrepreneurial mindset and analytical thinking
• Demonstrates ability to work both independently and as a member of local / global teams
• Excellent customer service skills and ability to meet client project deadlines
• Flexibility to switch between projects

• GMP manufacturing environment working with biologics and chemicals
• Personal Protective Equipment must be worn as required
• Normal office working conditions
• Will interact with a cross functional team
• Pace may be fast and job completion demands may be high

• Frequent lifting up to 25 lbs
• Frequent standing/walking to work in lab environment for extended periods
• Frequent sitting for extended periods to use computer

Mid‑Senior level

Full‑time

Management, Manufacturing, and Quality Assurance