Associate Principal Scientist, Biologics Analytical Research and Development

1 day ago

Rahway NJ United States Merck Full time

Job Description

Position Description:

Associate Principal Scientist, Biologics Analytical Research and Development (Onsite)

The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, 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.
  • Effective organizational, multi-tasking, oral/written communications skills, scientific leadership, and a desire to conduct research and publish.
  • Leading small groups of technical personnel and analytical projects.
  • Evidence of strong cross-functional collaboration in an academic or industrial setting.

Position Qualifications:

Education Minimum Requirement:

  • B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field with 10 years of relevant experience; or
  • Master's degree with 7 years of relevant experience; or
  • Ph.D. with 3 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).
  • 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.
  • 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.
  • Accurate and efficient 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).
  • Experience in data analytics, programming, or laboratory automation.

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 10%

Job Posting End Date: 11/28/2024

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