Prin. Scientist, Analytical R&D

Merck•Rahway, NJ

1d•Hybrid

About The Position

The Materials and Biophysical Characterization group in Analytical Research and Development is seeking a highly self-motivated and innovative scientist with deep knowledge and problem-solving skills in biotherapeutics characterization. The Materials and Biophysical Characterization team is responsible for building the mechanistic understanding of the interplay between formulation composition, stability, device, and process to ensure robustness and quality of drug substances and drug products in the biotherapeutics pipeline. As a Principal Scientist, you will be leading and/or contributing to projects in a diverse biotherapeutics pipeline by developing and implementing biophysical and particle characterization tools. In addition to your responsibilities as an individual contributor, you will also serve as a senior scientific leader and will be expected to mentor other team members in designing experiments, interpreting data, and delivering results in a timely manner. You are expected to use your scientific expertise to find creative solutions to challenging problems which require deep analytical insight and critical thinking. Additional responsibilities include authoring technical reports and regulatory documents, presenting technical data, and project management. You will have the opportunity to conduct and lead independent research, publish research findings, present at scientific conferences, and engage with various external scientific societies/organizations. This is an excellent growth and learning opportunity to work in an exciting, collaborative environment with a wide array of scientists from different divisions and make significant contributions towards our life-saving medicines.

Requirements

Ph.D. in Biophysics, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years of relevant industry experience.
OR M.S. with a minimum of 10 years of relevant industry experience.
Extensive experience in the analysis of biologics, protein/peptide stability, protein-protein interactions
Extensive experience with subvisible particle characterization methodologies and analytical control strategy development and execution.
Strong background in biophysical characterization assay development and implementation (e.g. Circular Dichroism (CD), Infrared Spectroscopy (IR), Differential Scanning Calorimetry (DSC), Analytical Ultracentrifugation (AUC))
Understanding of protein aggregation mechanisms and link between analytical methodologies for analysis.
Demonstrated ability to develop talent through good mentoring skills. Experience with matrix management and peer-to-peer coaching
Demonstrated ability for taking initiative, creativity, and innovative problem solving.
Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment
A strong team player with excellent oral and written communication skills; ability to work both independently and cross-functionally.
Experience with authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.
Established scientific reputation and external influence, supported by publications, patent authoring, external presentations at scientific meetings, membership in (or leading) cross-company working groups or consortia

Nice To Haves

Experience characterizing various biologics modalities (e.g. mAb, antibody-drug conjugates, fusion proteins, peptides)
Experience with characterization of lyophilized protein formulations
Experience with extraneous matter (EM) investigations for particle identification
Experience/knowledge in formulation development and relevant analytical method development

Responsibilities

Leading and/or contributing to projects in a diverse biotherapeutics pipeline by developing and implementing biophysical and particle characterization tools.
Serve as a senior scientific leader and will be expected to mentor other team members in designing experiments, interpreting data, and delivering results in a timely manner.
Use your scientific expertise to find creative solutions to challenging problems which require deep analytical insight and critical thinking.
Authoring technical reports and regulatory documents, presenting technical data, and project management.
Conduct and lead independent research, publish research findings, present at scientific conferences, and engage with various external scientific societies/organizations.