Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies.  Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!  

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 Downstream systems utilizing single use technology to include column chromatography using diverse resins including, capture, ion exchange, and multi-modal in both ready to process and self-pack columns, Microfiltration, Ultrafiltration/Diafiltration operations, viral inactivation/filtration operations, drug substance preparation through pack out and controlled rate freezing operations and associated In Process Analytical (IPA) methods. A familiarity with process control systems is essential
• A knowledge of UNICORN operating systems
• 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