Quality Control Analyst II

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

• Perform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documents
• Experience with plate-based assays e.g., ELISA, potency assays, and qPCR
• Create/revise SOPs, Protocols and Reports
• Practice safe work habits and adhere to safety procedures and guidelines
• Perform maintenance and cleaning of laboratory equipment
• SME to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non-conformances
• Update and track metrics for trending and reporting; stability and QC analytical data
• Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
• Exceptional communication and interpersonal skills
• Assists in training of new hires and retraining of QC laboratory staff, as needed
• Performs other duties as assigned

Qualifications

• Bachelor's Degree in Life Sciences discipline
• Minimum 3+ years’ experience in a cGMP analytical lab environment
• Must have the ability and skill to perform the detailed job requirements competently, safely, accurately, and proficiently 
• Self-starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skills
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable manner
• Able to use and learn standard office equipment and technology with proficiency
• Experience in Empower chromatography software

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. 
• Work is to be performed on site
• Possible weekend/off hours testing may be required

Physical Requirements

• Frequent standing/walking
• PPE as required
• Able to work upright and stationary and/or standing for typical working hours
• Able to lift and move objects up to 25 pounds