Associate Principal Scientist, Biologics Analytical Research & Development

Job Description

The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New Jersey research facility.  The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products.  The successful candidate must function well and be able to collaborate in a fast-paced, integrated, 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 have effective organizational, multi-tasking, oral/written communications skills, show 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. 

Qualifications
 

Education:

• B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field with 12 years of relevant experience; or Master's degree with 8 years of relevant experience; or Ph.D. with 4 years of relevant experience.

Required Experience and Skills:

• Strong background and experience in separations science

• Extensive experience with UPLC/HPLC analysis of biologics (e.g. SEC, RP, IEX)

• Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques

• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications

• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development

• A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.

• Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.

• Experience with matrix management and peer to peer coaching

• Accurately and efficiently documentation of experiments

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills:

• Understanding of protein degradation mechanisms and link between analytical 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 with complex glycan analysis and link to mechanisms of actions.

• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).

#AR&D

Required Skills:

Adaptability, Analytical Method Development, Assay Development, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Optimism, Process Analytical Technology (PAT), Protein Analysis, Teamwork

Preferred Skills:

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