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

Rentschler Biopharma•Milford, MA

3d•Onsite

About The Position

This is a 6-month contract role for a Scientist in Quality Control Analytical Development. The primary focus is on supporting the qualification and validation of analytical methods for biologic drugs and process-related impurities. The role involves executing experiments for the validation of molecular biology assays, including ELISAs for residual HCP and residual protein A, and relative potency assays, as well as qPCR. The scientist will collaborate within a group to perform analytical method development, qualification, and validation under cGMP, in conjunction with the Quality Control unit. This position requires applying expertise in molecular biology, cell biology, and/or immunochemistry to the analytical development team throughout the lifecycle of procedures. Responsibilities also include participating in the technology transfer of analytical methods into QC, method transfer, method validation, method development, and reviewing/revising SOPs and authoring reports, protocols, and other documentation. Collaboration with other labs for method transfer to QC GMP labs and providing training and work direction for group members are also key aspects of this role.

Requirements

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) in a cGMP environment.
Experience utilizing Spectramax 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 ability to 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.
Computer skills to include full competence with Microsoft Word, Power Point & Excel.

Nice To Haves

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.

Responsibilities

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.
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.