Principal Scientist, Bioanalytics

Merck•Billerica, MA

6d•Onsite

About The Position

In the New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) department, the Principal Scientist role is a scientific and operational role in Research and Development (R&D). Our company is committed to bringing transformational medicines to patients, and you will collaborate in a matrixed environment with other passionate functional experts to deliver novel biotherapeutics. You will be responsible for the development and fit-for-purpose validation of bioanalytical methods to be applied in sample analysis for molecules in discovery and development phases. Your work will support the characterization of multiple molecules and modalities, including multi-specific NBEs, antibody-drug conjugates, antibody oligonucleotide conjugates (AOCs), and other biologics, from molecule design through preclinical and clinical phases, thus fulfilling internal and regulatory requirements. Representative technologies could include innovative immunochemical and ligand binding techniques such as ELISA, MSD-ECLA, Gyrolab, and others. Additional duties will include development of complex experimental study designs, interpretation of analytical data, good knowledge of immunogenicity, and technical report writing according to current company and industry standards. You will be responsible for ensuring timely delivery, with appropriate quality, of LBA bioanalytical deliverables (method development, qualification, and its application to in-vivo animal studies), and if needed, responsible for conducting/supervising critical reagent characterization. You will be able to recommend data decisions to the lab manager by providing solid results, findings and technical solutions to project issues/problems. You will be able to conduct scientific literature research to address complex technical issues and evaluate and implement potential new analytical strategies and technologies as needed. You may also be responsible for monitoring bioanalytical studies at contract research organizations (CROs).

Requirements

Ph.D. in Biochemistry, Biology, Chemistry, or related field.
Expertise in PK, bioanalytics, immunogenicity, and/or relevant sciences.
Experience with biological molecules (NBEs, ADCs, AOCs, other novel modalities).
Experience with ligand binding techniques such as ELISA, MSD-ECLA, Gyrolab, and related.
Excellent experimental design and troubleshooting skills.
Excellent data analysis & data mining skills.
Experience using, optimizing, and troubleshooting laboratory instrumentations.
Able to conduct appropriate experiments and manage work hours and priorities to meet project timelines.
Experience reviewing bioanalytical methods, qualifications, validations, and bioanalytical study reports.
Knowledge of Watson LIMS, GraphPad Prism, Veeva Vault and/or related software.
5-7+ years of professional experience in regulated bioanalysis, supporting drug discovery and/or development projects.
Fluent spoken and written English.

Nice To Haves

Solid understanding of translational sciences, regulatory requirements and work packages for biotherapeutics (nonclinical and clinical).
General knowledge of disease areas (e.g. Immunology, Oncology, etc.), and an understanding of biology and pharmacology.
Experience in a global matrixed environment.

Responsibilities

Development and fit-for-purpose validation of bioanalytical methods for sample analysis of molecules in discovery and development phases.
Support characterization of multiple molecules and modalities (NBEs, ADCs, AOCs, other biologics) from molecule design through preclinical and clinical phases.
Develop complex experimental study designs.
Interpret analytical data.
Write technical reports according to company and industry standards.
Ensure timely and quality delivery of LBA bioanalytical deliverables (method development, qualification, and application to in-vivo animal studies).
Conduct/supervise critical reagent characterization if needed.
Recommend data decisions to the lab manager by providing solid results, findings, and technical solutions.
Conduct scientific literature research to address complex technical issues.
Evaluate and implement potential new analytical strategies and technologies.
Monitor bioanalytical studies at contract research organizations (CROs).