Scientist, Quality Control Analytical Development
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. The Quality Control Scientist, Analytical Development, is a key member of the Quality Control team and the team is responsible for ensuring the methods are in an appropriate GMP status prior to GMP manufacturing by leading the validation/qualification/transfer of methods as appropriate. The Quality Control Scientist, Analytical Development, will execute Analytical Development activities, investigations, and data evaluation in a GMP environment to ensure compliance based on regulatory and industry standards. Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.
Requirements
- Bachelor's degree in molecular biology, biochemistry, or equivalent biological science with minimum of 8+ years of related experience in a cGMP environment
- Master’s degree with 5+ years of experience
- PhD – degree with 3+ years of experience
- Strong hands-on experience operating and troubleshooting Cytiva based Biacore systems using Biacore Insight required
- Strong understanding of molecular biology assays in support of product quality testing for Biologics drug substances/drug products
- Experience with analytical characterization of biologics is expected
- Strong organizational and time management skills to enable prioritization of the individual’s work schedule to meet deadlines
- Must be able to communicate effectively with managers, peers, and clients
- Must demonstrate effectiveness in the ability to train others as needed
- Strong knowledge and expertise of quality requirements pertinent to pharmaceutical AD labs
- Strong working knowledge of laboratory safety including standard precautions associated with hazardous & biohazardous material handling
Nice To Haves
- Utilization of Spectramax M5 or M2 plate readers and the associated Softmax GMP software a plus
- Experience with drug substances, drug products, intermediates, and experience with monoclonal antibodies is desired
- Experience in other biophysical characterization methods CE (capillary electrophoresis), chromatography, SEC/RP/IEX-U(H)PLC, SDS-CGE, iCIEF, CIEX, Peptide mapping is a plus
- Computer skills to include full competence with Microsoft Word, Power Point & Excel
Responsibilities
- Laboratory role to support the qualification, and validation of analytical methods for biologic drugs and process related impurities
- Primary focus on the execution experiments to support the validation of Biacore SPR and ELISAs for residual HCP, residual protein a, relative potency, and other molecular biology assays as appropriate
- Work collaboratively within a group of scientists to perform analytical method development, optimization, qualification, leading to validation under cGMP in collaboration with the Quality Control unit
- Apply expertise in surface molecular biology with a focus on surface plasmon resonance and immunochemistry to analytical development team across the lifecycle of the procedures
- Participate in the transfer of analytical methods into QC and the subsequent analytical method qualification, method validation, method development, and/or external transfer
- Review & revise SOPs and/or author reports, protocols & other documentation as appropriate
- Collaborate with other labs to prepare methods for transfer to the QC GMP labs
- Provide training and work direction for group members as required
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
