Associate Principal Scientist, Biologics Analytical Research & Development

Merck; New Jersey; Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Merck in Rahway, New Jersey seeks an Associate Principal Scientist to lead analytical method development for complex biologics, enabling drug substance and product development. The role emphasizes design, qualification, transfer, and troubleshooting of assays in a fast-paced, collaborative team setting.

The candidate will work across chemistry, biology, and informatics, with responsibilities including development of new platforms, benchmarking against industry standards, and technical leadership

Formación

• B.S./M.S./Ph.D. with relevant experience in analytical biology/biochemistry.
• Strong background in separations and HPLC/UPLC of proteins.
• Experience with assay development for release/characterization/stability testing.
• Familiarity with DOE/QbD and statistical data analysis.
• Ability to lead assay development and cross-functional transfers.
• Experience authoring technical reports and contributing to filings.

Responsabilidades

• Develop, qualify, implement and troubleshoot analytical methods for monoclonal proteins.
• Lead design-of-experiments and data interpretation for complex biologics.
• Transfer assays to manufacturing and support regulatory filings.
• Collaborate across biology, chemistry, and informatics to enable product development.

Conocimientos

Separation science

UPLC/HPLC analysis

Biologics analysis

QbD/DOE principles

Assay development

Cross-functional teamwork

Regulatory writing support

Educación

B.S. in Chemistry/Biochemistry/Engineering with 12 years experience

M.S. with 8 years experience

Ph.D. with 4 years experience

Descripción del empleo

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.

Education :

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

US and Puerto Rico Residents Only:

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