Sr. Scientist Biologics Analytical R&D

Merck•Rahway, NJ

1d•Hybrid

About The Position

The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for a Senior Scientist position available at its Rahway, New Jersey research facility. The Senior Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The qualified candidate will be responsible for development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins. Applicants must have effective organizational, multi-tasking, oral/written communications skills, show scientific leadership, and a desire to conduct research and publish. Experience leading small groups of technical personnel and analytical projects will aid in distinguishing candidates. Evidence of strong cross-functional collaboration in an academic or industrial setting is also preferred.

Requirements

B.S. with a minimum of 8 years of experience in the Pharmaceutical Industry or M.S. with a minimum of 5 years of experience in the Pharmaceutical Industry or Ph.D. in analytical chemistry/biochemistry
Strong background and experience in separations science
Extensive experience with UPLC/HPLC analysis of biologics (e.g., SEC, RP, IEX) and CE techniques
Experience in process- or impurity-related residual assay development.
Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications.
Ability to design, execute and development of methods for release, characterization, and stability testing of clinical trial material and in support of product and process development.
A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays.
Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
Demonstrated scientific ability through publications and presentations in scientific conferences.

Nice To Haves

Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP<1033>.
Experience in representing analytical functional area on project teams.
Strong knowledge of protein structure and degradation pathways.
Mass spectrometry for large molecules.
Molecular biology (PCR, DNA extraction) and immunoassay (ELISA, gel electrophoresis) techniques.
Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).
Experience leading small groups of technical personnel and analytical projects.
Evidence of strong cross-functional collaboration in an academic or industrial setting.

Responsibilities

Development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins.
Design, execute and development of methods for release, characterization, and stability testing of clinical trial material and in support of product and process development.
Plan assay optimization and documentation to meet program deadlines.
Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.