Scientist, Quality Control Analytical Development (6-month Contract)

Duties And Responsibilities

• Support the qualification and validation of analytical methods for biologic drugs and process related impurities.
• Execute experiments to support the validation of molecular biology assays including ELISAs for residual HCP, residual protein a, and relative potency assays as well as qPCR.
• Collaborate with the analytical development team to perform method development qualification or validation under cGMP.
• Work collaboratively within a group of scientists to support the Quality Control unit in method transfer, method validation, and method development.
• Review and revise Standard Operating Procedures (SOPs) and/or author reports, protocols, and other documentation as appropriate.
• Prepare methods for transfer to the QC GMP labs and provide training and work direction for group members as required.

Qualifications

• Bachelor’s Degree in chemistry or a biological science with a minimum of 5+ years of related experience (or master’s degree with 2+ years of experience).
• Minimum of 5+ years of experience in a cGMP environment.
• Experience utilizing Spectramax M5 or M2 plate readers and the associated Softmax GMP software.
• 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 the ability to prioritize work schedules to meet deadlines.
• Effective communication skills with managers, peers, and clients.
• Effectiveness in training 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 and biohazardous material handling.
• Experience with drug substance, drug products, intermediates, and monoclonal antibodies.
• Experience in other biophysical characterization methods such as CE (capillary electrophoresis), chromatography, SEC/RP/IEX-U(H)PLC, SDS-CGE, iCIEF, CIEX, Peptide mapping is a plus.
• Full competence with Microsoft Word, PowerPoint, and Excel.