Scientist, Upstream Process Development

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.

Duties and Responsibilities

• Development of scale-able and robust upstream processes including process characterization, and/or technology transfer to clinical and commercial GMP manufacturing while meeting the project deliverables
• Design and execute experiments related to development, optimization, and scale down/ scale-up of all mammalian cell culture unit operations
• Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
• Ability to work in a team environment and drive the success of the team
• Apply advanced statistical techniques to design experiments related to process development and characterization
• Author high-quality documents, including technical reports, SOPs, and experimental protocols
• Serve as a Process Development representative and participate in cross functional meetings
• Contribute to scale up activities and draft technical transfer related documents (e.g. process description, process flow diagram)
• Review batch records and provide comments
• Support MFG floor activities and process deviations including effective CAPAs
• Provide technical support (e.g. process/operational gap identification and troubleshooting) to MSAT and the manufacturing group
• Compile and present data at client project teams and author reports
• Contribute to the overall operations of process sciences lab and infrastructure improvements
• Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives
• Train and/or lead Associate Scientists

Qualifications

• A university degree and 5+ years of related experience
• A Master's degree and 3+ years
• A PhD and 1+ years(s) of experience
• Solid theoretical knowledge and hands-on experience cell culture process development, including aseptic technique and bioreactor operation
• Desirable experiences: Cell Banking, Harvest Unit Operations, AMBR operation, MODDE statistical tools, ICH guidelines
• The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills
• Advanced ability with Microsoft Office (Word, Excel, and PowerPoint)
• 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 of hours to support laboratory and MFG floor activities. Weekend and holiday hours are compensated per HR company policies
• Flexibility to switch between projects

Working Conditions

• Laboratory environment working with chemical reagents and genetically modified cells
• Personal Protective Equipment must be worn as required
• Normal office working conditions: computer, phone, files, fax, copier
• Will interact with other people
• Pace may be fast and job completion demands may be high

Physical Requirements

• PPE as required
• Frequent lifting up to 10 lbs
• Frequent standing/walking to work in lab environment for extended periods
• Frequent sitting for extended periods to use computer