Senior Scientist, Process Development Analytics

Rentschler Biopharma•Milford, MA

61d•Onsite

About The Position

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.

Requirements

A university degree and 8 + years of related experience
A Master’s degree and 5 + years
A PhD and 2 + years of experience
Hands-on experience with analytical technique such as: HPLC/UPLC, cGE / iCIEF , bioassay, activity assay, ELISA, qPCR, and microbial testing
Knowledge and understanding of protein manufacturing process (upstream/downstream) is is preferred
Proficient in Microsoft Office (Word, Excel, Power Point, SharePoint)
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
The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills

Nice To Haves

Experience with monoclonal antibodies, bispecific , fusion proteins, and enzymes is preferred

Responsibilities

Design, lead, and execute method development in support of internal and external partners for use within quality control departments for clinical and commercial manufacturing
Lead, execute, review, and present high-throughput testing of in-process sample for process development work packages
Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives
Coordinate with management for the day-to-day execution of experiments in lab to ensure proper personnel coverage for timely completion
Author high-quality documents, including technical reports , SOPs, and experimental protocols
Identify , evaluate, and implement new and existing technologies to improve testing efficiency, control and understanding
Provide alignment between development and quality control laboratories for upcoming sample transfer and testing requests
Coordinate technical transfer of established methods to quality control and clients
Provide technical support Quality Control and Manufacturing floor activities
Serve as PD representative and participate in cross functional meetings
Oversee ordering and tracking of routine and client-billable consumables
Lead, train, and mentor junior lab staff
Interpret analytical data and understand relation to manufacturing process steps
Review data packages and compile slides to present at client project presentations
Contribute to the overall operations of process science lab and infrastructure improvements
Ability to work in a team environment and drive the success of the projects