Associate Principal Scientist, Analytical R&D

Merck•Rahway, NJ

1d•Onsite

About The Position

Associate Principal Scientist, Biologics Analytical Research & Development Our Research Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough. The Biologics Analytical Research & Development department (BAR&D) is seeking an Associate Principal Scientist position at the Rahway, New Jersey site. This role is a laboratory-based scientific role tasked with solving complex analytical challenges, to enable development of Biologics drug products. The successful candidate must function well in a collaborative, fast-paced, 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. Responsibilities include development of new assay platforms, benchmarking current approaches/techniques to industry standards, and providing technical leadership of design of experiments and data interpretation. Applicants must be highly organized, possess excellent oral/written communications skills, display 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

Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field, B.S. with 10+ yrs, MS with 7+ yrs, or Ph.D. with 3+ yrs of relevant experience.
Hands-on experience in separation sciences with chromatography, (e.g. SEC, RP, IEX, HILIC) and/or experience with capillary electrophoresis (CE) analysis (e.g. CE-SDS, iCIEF) for biologics.
Experience with residual impurity assay development using molecular biology and immunoassay techniques (ELISA, qPCR, etc.).
Ability to co-design, draft, execute/direct work related to method bridging, comparability, the setting of specifications, etc., from protocol to final report.
Ability to design, execute and/or direct the development of release/stability and characterization methods for clinical trial material and in support of product/process development per ICH Q2 (R2) guidance through method qualification.
Excellent oral and written communication skills; ability to work both independently and cross-functionally.
Authoring and reviewing of SOPs, technical reports, publications and sections of regulatory filings (e.g., IND, BLA).
Experience with matrix management and peer to peer coaching.
Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Nice To Haves

Ability to design, execute and/or direct the development of release/stability and characterization methods for clinical trial material and in support of product/process development per ICH Q2 (R2) guidance through method qualification.
Broad knowledge on the panel of biologics assays, charge & size variants, glycans, purity/impurity.
Understanding of protein degradation mechanisms and the link between analytical/orthogonal methodologies for analysis.
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.
Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)
Experience in data analytics

Responsibilities

development of new assay platforms
benchmarking current approaches/techniques to industry standards
technical leadership of design of experiments and data interpretation
development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins