Associate Principal Scientist, Biologics Analytical Research & Development

MSD•Rahway, NJ

1d•$142,400 - $224,100•Onsite

About The Position

The Biologics Analytical Research & Development department within the Research & Development Division is seeking an Associate Principal Scientist for its Rahway, New Jersey research facility. This laboratory-based scientific role addresses complex analytical problems at the interface of biology, chemistry, and laboratory informatics to enable development of biologics drug substances and drug products. The successful candidate will work collaboratively in a fast-paced, integrated, multidisciplinary team. The role involves developing, qualifying, implementing, troubleshooting, and transferring analytical methods for monoclonal proteins and other complex therapeutic proteins. It also includes developing new assay platforms, benchmarking current methods against industry standards, and providing technical leadership for design of experiments and interpretation of data. The candidate should demonstrate strong organization, multitasking, communication, and scientific leadership skills, as well as an interest in conducting research and publishing. Experience leading small groups of technical personnel and analytical projects is useful; strong cross-functional collaboration in an academic or industrial setting is preferred.

Requirements

A B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or a related field with 12 years of relevant experience; or a master's degree with 8 years of relevant experience; or a Ph.D. with 4 years of relevant experience.
Strong background and experience in separations science.
Extensive experience with UPLC/HPLC analysis of biologics, such as SEC, RP, and IEX.
Extensive experience developing process- and impurity-related residual assays using molecular biology and immunoassay techniques.
Background in analytical methodologies and sound scientific understanding of Critical Quality Attributes, QbD, and DOE principles, as well as data analysis and statistics for setting specifications.
Ability to design, execute, and/or direct development and qualification of release, characterization, and stability assays.
Strong teamwork and oral and written communication skills.
Ability to work independently and cross-functionally.
Experience with matrix management and peer-to-peer coaching.
Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Nice To Haves

Experience leading small groups of technical personnel and analytical projects.
Evidence of strong cross-functional collaboration in an academic or industrial setting.
Understanding of protein degradation mechanisms and the relationship to analytical methodologies.
Experience qualifying, validating, and transferring assays to a GLP or regulated laboratory environment, as described in ICH Q2 and USP <1033>.
Experience representing the analytical functional area on project teams.
Experience with complex glycan analysis and its relationship to mechanisms of action.
Experience analyzing various biologic modalities, such as monoclonal antibodies, antibody-drug conjugates, and fusion proteins.

Responsibilities

Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins and other complex therapeutic proteins.
Develop new assay platforms and benchmark current approaches and techniques against industry standards.
Provide technical leadership for design of experiments and data interpretation.
Design, execute, and/or direct development and qualification of release, characterization, and stability assays for clinical trial material and product and process development.
Plan assay optimization and documentation to meet program deadlines.
Work independently on assay development and cross-functionally to support successful assay transfer.
Author and review internal technical reports, sections of regulatory filings such as INDs and BLAs, and external scientific publications.
Accurately and efficiently document experiments.
Represent the analytical functional area on project teams, as applicable.