Associate Scientist , Process Development Analytics; Bioanalytical Assays

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.

We are recruiting for a proactive and “hands-on” Associate Scientist I, Process Development. Analytics. They will demonstrate flexibility, adaptability, and can work in a fast paced, rapidly changing CDMO environment. They are self-motivated, accountable, inquisitive, and have excellent organizational and communication skills. They can multi-task, while delivering excellent customer service.

• Routine testing of in-process samples for process development activities of proteins with a focus on bioanalytical assays, such as HCP, residual Protein A ELISA, binding potency, activity assays, residual DNA by qPCR
• Optimization and troubleshooting of bioanalytical assays by learning assay principles and equipment capabilities
• Decrease routine in-process assay turnaround times by increasing lab efficiencies and employing high-throughput methodologies
• Interpret analytical data and understand relation to manufacturing process steps
• Provide complete data packages for review and compile slides for client presentations
• Be proficient in LIMS and enter / review all LIMS results prior to release
• Author high-quality documents, including technical reports, TPs and experimental protocols as needed
• Provide technical support (e.g., method and instrument troubleshooting) to QC group as needed

• Bachelor's degree in STEM with 1+ year(s) of relevant experience
• The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills
• Proficient in Microsoft Office (Word, Excel, Power Point, SharePoint)

• Experience with monoclonal antibodies, bispecific, fusion proteins, and enzymes
• Experience with method development, qualification, and validation
• Hands-on experience with analytical techniques such as plate-based assays, generic HCP ELISA, and qPCR
• Knowledge and understanding of protein manufacturing process (upstream/downstream)

• Laboratory environment working with chemical reagents and analytical equipment
• 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
• Frequent lifting up to 10lbs
• Frequent standing/walking to work in lab environment for extended periods
• Frequent sitting for extended periods to…