Scientist, Quality Control Analytical Development

Scientist, Quality Control Analytical Development page is loaded## Scientist, Quality Control Analytical Development locations:
Milford, MA, United Statestime type:
Full time posted on:
Posted 5 Days Agojob requisition :
JR2556
** 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
*** Laboratory role to support the qualification and validation of analytical methods for biologic drugs and process related impurities
* Primary focus on the execution of experiments to support the validation of molecular biology assays including but not limited to ELISAs for residual HCP, residual protein a, and relative potency assays as well as qPCR
* Work collaboratively within a group of scientists to perform analytical method development qualification or validation under cGMP in collaboration with the Quality Control unit
* Apply expertise in molecular biology, cell biology and/or immunochemistry to analytical development team across the lifecycle of the procedures
* Participate in the technology transfer of analytical methods into QC and analytical method qualification Method transfer, method validation, method development
* 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
** Qualifications
* ** Bachelor’s Degree in chemistry or a biological science with minimum of
* 5+ years of related experience (or master’s degree with 2+ years of experience) in a cGMP environment
* ** Experience utilizing Spectra max M5 or M2 plate readers and the associated Softmax GMP software required
*** Strong understanding of molecular biology assays in support of the product quality testing for Biologics drug substances/drug products
* Experience with analytical characterization of biologics is expected
* Strong organizational, time management skills, and prioritize work schedule to meet deadlines
* Must be able to communicate effectively with managers, peers, and clients
* Must demonstrate effectiveness in 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
* Experience with drug substance, drug products, intermediates, as well as 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
** Working Conditions
*** Laboratory environment working with chemical reagents and analytical equipment
* Normal office working conditions: computer, phone,…