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

• In accordance with test method SOP’s, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, Media performance, Growth promotion and Microbial Identifications
• Perform analytical tests as needed such as pH, basic spectrophotometric methods such as A280nm and A550nm, and potency testing
• Perform environmental monitoring of cleanrooms and water system sampling
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, Eu. Ph., GLP, GDP, QSR, and CGMP regulations
• Investigate, assess, and troubleshoot assay and/or equipment problems
• Notify QC Manager immediately when a deviation, an aberrant result, or an OOT/OOS result is discovered.  Initiate and participate in authoring investigation reports
• Support investigations of deviations and prepare exception documents, utilizing problem solving tools as needed
• Participate in method qualifications, validations, and transfers
• Always maintain sample tracking and integrity until analyses are reviewed
• Prepare and complete change control requests using electronic systems
• Support Lean principles such as 5S throughout daily work activities
• Ensure personal training requirements are met and that training records are current
• Ensure analytical equipment is calibrated and well maintained at all times
• Perform general lab maintenance.  Order supplies as needed, store materials as indicated and discard expired materials as per manufacturer or test method recommendations

Qualifications

• Bachelor’s Degree in STEM
•  3+ years of experience in biopharmaceutical Quality Control in a GMP environment with specific experience in microbiological testing and sampling
• Ability to participate in holiday and weekend coverage is required
• Demonstrated experience using relevant QC procedures, specifications, regulations and standards
• Knowledge and control of lab testing equipment including determining when and what kind of maintenance is needed
• Demonstrated competence in use of computer software, including relevant applications such as Microsoft Office and LIMS
• Knowledge of CGMPs regulations including GMP practices for method transfer, qualification and validation
• Demonstrated understanding of quality systems including change control, deviations and CAPAs
• Knowledge of aseptic technique and impact of product and facility contamination. This includes the performance of microbial identifications and relevant investigations to understand the source of contamination and means to prevent or minimize further occurrence
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner
• Strong written and verbal language skills to effectively read and write SOP’s, related lab reports, and communicate technical information to audiences with varying levels of technical knowledge
•  Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint

Working Conditions

• Laboratory environment working with chemical reagents and analytical equipment
• Entry into utilities rooms for water sampling
• Clean Room gowning and scrubs
• Personal Protective Equipment must be worn as required
• Normal office working conditions: computer, phone, files, fax, copier

Physical Requirements

• Participation in a holiday and weekend is 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