Quality Control Associate Scientist II, Analytical 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

• Utilization of a variety of analytical techniques focused on controlling drug substance or drug product target profiles including but not limited to the following: (U)HPLC including SEC/RP/IEX/HIC/HILIC methods, reducing and non-reducing SDS-CGE, iCIEF, Peptide mapping, ELISAs, and qPCR.
• Preparation of reagents, buffers, mobile phases, receipt of samples, and general laboratory housekeeping.
• Execution of laboratory experiments to support the transfer, qualification, and validation of analytical methods primarily for biologic drugs and the associated product/process related impurities.
• Collaborate with team members and other groups to prepare methods for implementation in the quality control release team or other external labs.
• Participate in continuous improvement initiatives that impact production, increase efficiency, solve problems, generate cost savings, improve quality & provide new product support.

Qualifications

• Bachelor’s Degree in biochemistry, chemistry, or equivalent life science with 3+ years of industry experience
• Must be able to communicate effectively with management and peers
• Proficient in Microsoft Office (e.g. Word, Excel, PowerPoint, SharePoint)
• Previous experience working with hazardous materials in a laboratory environment with a focus on analytical method validation or development
• At least 1 year of experience working in a GxP environment with a preference for cGMP experience
• Strong organizational and time management skills with the ability to prioritize schedule to meet deadlines

Preferred Qualifications

• Experience in HPLC techniques including understanding chromatographic principles, the ability to apply knowledge to evaluate method performance, and troubleshoot both method and instrumentation issues strongly preferred
• Experience using Empower 3 Enterprise strongly preferred
• Previous experience with quality records (Change Controls, CAPAs, OOXs, etc.) is a plus
• Knowledge of biologic drug substance testing for small molecule impurities is a plus
• Previous experience utilizing molecular biology techniques such as ELISAs, western blotting, or qPCR is a plus

Working Conditions

• Laboratory environment working with chemical reagents and analytical equipment 
• Normal office working conditions: computer, phone, files, fax, copier
• Personal Protective Equipment must be worn as required
• Minimum travel required

Physical Requirements

• Frequent lifting up to 10 lbs.; frequent standing/walking
• Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods