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.

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) :

Preferred Technical Experience

General Attributes

Working Conditions

Physical Requirements

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Management, Manufacturing, and Quality Assurance

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