Associate Principal Scientist, Biologics Analytical R&D

About the role

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.

Responsibilities

• Solve complex analytical challenges to enable development of Biologics drug products
• Develop, qualify, implement, troubleshoot and transfer analytical methods for monoclonal proteins or other complex therapeutic proteins
• Develop new assay platforms
• Benchmark current approaches/techniques to industry standards
• Provide technical leadership of design of experiments and data interpretation
• Lead small groups of technical personnel and analytical projects
• Conduct research and publish

Qualifications

• Education: 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 (SEC, RP, IEX, HILIC) and/or experience with capillary electrophoresis (CE) analysis (CE-SDS, iCIEF)
• 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 appropriate sections of regulatory filings (e.g., IND, BLA)
• Experience with matrix management and peer to peer coaching

Preferred Experience and Skills

• Design of Experiment principles including statistical data analysis using JMP, MiniTab, FusionAE, etc.
• 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
• Experience in representing analytical functional area on project teams
• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)