About this role
Associate Principal Scientist in Biologics Analytical Research & Development at Merck’s Rahway, New Jersey site. The role develops, qualifies, implements, troubleshoots, and transfers analytical methods for monoclonal and complex therapeutic proteins.
Key Responsibilities
- Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal and complex therapeutic proteins
- Develop new assay platforms and benchmark against industry standards
- Provide technical leadership for design of experiments and data interpretation
- Lead method bridging, comparability, and specifications setting from protocol to final report
- Author and review SOPs, technical reports, publications, and regulatory filing sections (IND, BLA)
Technical Overview
Laboratory-based analytical R&D focusing on separation sciences using chromatography (SEC, RP, IEX, HILIC) and/or capillary electrophoresis (CE-SDS, iCIEF). Owns residual impurity assays (ELISA, qPCR), performs method bridging/comparability/specification setting, and executes release/stability characterization aligned to ICH Q2 (R2) for method qualification, including SOP/reporting and regulatory filing support (IND, BLA).
Ideal Candidate
The ideal candidate is an experienced Associate Principal Scientist in biologics analytical R&D with hands-on separation sciences expertise, including chromatography (SEC, RP, IEX, HILIC) and/or capillary electrophoresis (CE-SDS, iCIEF). They have led residual impurity assay development and are strong in method bridging, comparability, specifications, and ICH Q2 (R2)-aligned method qualification, with proven SOP/report/regulatory filing authorship and cross-functional leadership.
Must-Have Skills
Hands-on experience in separation sciences with chromatography (SECRPIEXHILIC) and/or experience with capillary electrophoresis (CE) analysis (CE-SDSiCIEF) for biologicsExperience with residual impurity assay development using molecular biology and immunoassay techniques (ELISAqPCRetc.)Ability to co-designdraftexecute/direct method bridgingcomparabilityand the setting of specifications from protocol to final reportAbility to designexecute 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 qualificationExcellent oral and written communication skillsAuthoring and reviewing of SOPstechnical reportspublications and sections of regulatory filings (INDBLA)Experience with matrix management and peer to peer coachingAbility to deliver complex objectives under aggressive timelines
Nice-to-Have Skills
Ability to designexecute and/or direct the development of release/stability and characterization methods (preferred continuation mentioned but truncated)
Tools & Platforms
SOPs (Standard Operating Procedures)IND (Investigational New Drug)BLA (Biologics License Application)
Required Skills
separation scienceschromatographySECRPIEXHILICcapillary electrophoresisCE-SDSiCIEFresidual impurity assay developmentmolecular biologyELISAqPCRmethod bridgingcomparabilitysetting of specificationsrelease/stability methodscharacterization methodsICH Q2 (R2)method qualificationSOP authoringtechnical reportspublicationsregulatory filings (INDBLA)matrix managementpeer to peer coaching
Hard Skills
separation scienceschromatographySEC (Size Exclusion Chromatography)RP (Reversed Phase)IEX (Ion Exchange Chromatography)HILIC (Hydrophilic Interaction Liquid Chromatography)capillary electrophoresis (CE)CE-SDS (Sodium Dodecyl Sulfate Capillary Electrophoresis)iCIEF (imaged Capillary Isoelectric Focusing)residual impurity assay developmentmolecular biologyimmunoassay techniquesELISA (Enzyme-Linked Immunosorbent Assay)qPCR (quantitative Polymerase Chain Reaction)method bridgingcomparabilitysetting of specificationsrelease/stability methodscharacterization methodsICH Q2 (R2) guidancemethod qualificationSOP authoringtechnical report writingpublication writingregulatory filings sections authoring and reviewingIND (Investigational New Drug)BLA (Biologics License Application)matrix managementpeer to peer coaching
Soft Skills
collaborationscientific leadershipexcellent oral communication skillsexcellent written communication skillshighly organizedindependent and cross-functional worktechnical group leadershipcross-functional collaborationability to deliver complex objectives under aggressive timelines
Keywords for Your Resume
Associate Principal ScientistBiologics Analytical Research & DevelopmentBAR&Dseparation scienceschromatographySECSize Exclusion ChromatographyRPReversed PhaseIEXIon Exchange ChromatographyHILICHydrophilic Interaction Liquid Chromatographycapillary electrophoresisCE-SDSSodium Dodecyl Sulfate Capillary ElectrophoresisiCIEFimaged Capillary Isoelectric Focusingresidual impurity assayELISAEnzyme-Linked Immunosorbent AssayqPCRquantitative Polymerase Chain ReactionICH Q2 (R2)method qualificationSOP
Deal Breakers
Must have hands-on chromatography (SEC, RP, IEX, HILIC) and/or capillary electrophoresis (CE-SDS, iCIEF) for biologics, Must have residual impurity assay development experience using molecular biology and immunoassays (ELISA, qPCR)
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