Scientist, Analytical R&D

MSDRahway, NJ
Onsite

About The Position

The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for a Scientist position in Rahway, New Jersey. The 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. Applicants must have effective organizational, multi-tasking, oral/written communications skills, show scientific leadership, and a desire to conduct research and publish. Evidence of strong cross-functional collaboration in an academic or industrial setting is also preferred.

Requirements

  • BA/BS in analytical chemistry/biochemistry or related field with a minimum of 3 years of experience in the Pharmaceutical Industry, or M.S. with a minimum of 0+ year relevant experience.
  • Prior experience in a laboratory environment
  • Ability to develop and apply basic principles and scientific concepts to execute work in a laboratory setting
  • Execute routine experiments and data interpretation with appropriate technical guidance
  • Ability to operate and troubleshoot analytical methods
  • Understanding of the fundamentals in separations science
  • Experience with UPLC/HPLC analysis of biologics (e.g., SEC, RP, IEX) and CE techniques or molecular biology (PCR, DNA extraction) and immunoassay (ELISA, gel electrophoresis) techniques
  • Ability to work within overall project timelines to manage prioritization and execution of individual deliverables with appropriate supervision
  • Demonstrated experience working within collaborative team environments
  • Experience in authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications
  • Adaptability
  • Analytical Chemistry
  • Analytical Development
  • Analytical Method Development
  • Antibody Drug Conjugates (ADC)
  • Cell-Based Assays
  • Cross-Functional Collaboration
  • Enzyme Linked Immunosorbent Assay (ELISA)
  • Good Manufacturing Practices (GMP)
  • Immunoassays
  • Immunoprecipitation
  • Interpersonal Relationships
  • Laboratory Automation
  • Laboratory Information Management System (LIMS)
  • Laboratory Techniques
  • Mammalian Cell Culture
  • Multitasking
  • Oral Communications
  • Pharmaceutical Management
  • Prioritization
  • Real Time Polymerase Chain Reaction (qPCR)
  • Self Motivation
  • Standard Operating Procedure (SOP) Writing
  • Technical Writing

Nice To Haves

  • Past experience working as part of a project team
  • Strong knowledge of protein structure and degradation pathways.
  • Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)
  • Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles
  • Prior experience with Microsoft Office and other research applications (e.g., RLIMS, ELN, Empower)
  • Experience in data analytics, programming, or laboratory automation

Responsibilities

  • Development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins.
  • Solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products.
  • Conducting research and publishing findings.
  • Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.

Benefits

  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
  • annual bonus
  • long-term incentive
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