Rentschler Biopharma
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.
Duties and Responsibilities
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
Qualifications 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
Preferred Technical 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
General Attributes
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
Working Conditions
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
Physical Requirements
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
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Management, Manufacturing, and Quality Assurance
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Duties and Responsibilities
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
Qualifications 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
Preferred Technical 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
General Attributes
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
Working Conditions
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
Physical Requirements
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
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Management, Manufacturing, and Quality Assurance
#J-18808-Ljbffr