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Merck KGaA Darmstadt Germany - Rahway, NJ

posted 2 months ago

Full-time - Senior
Rahway, NJ
Chemical Manufacturing

About the position

The Associate Principal Scientist in Mass Spectrometry will be a key player in the Translational Molecular Biomarkers (TMB) team, responsible for developing and validating mass spectrometry-based assays to support clinical trials across various therapeutic areas. This role requires strong technical expertise in liquid chromatography and mass spectrometry, particularly in quantifying peptides and proteins from formalin-fixed, paraffin-embedded (FFPE) tissue specimens. The candidate will collaborate closely with cross-functional teams and outsourcing partners to ensure the successful implementation of biomarker assays in clinical development.

Responsibilities

  • Develop and validate mass spectrometry-based assays within TMB for all therapeutic areas and phases of clinical development.
  • Focus on workflows and capabilities to develop mass spectrometry assays in tissue, particularly FFPE tissue.
  • Assist in the transition of biomarker assays from Basic Research to Clinical by providing technical guidance on fit-for-purpose assay validation.
  • Interface with scientists and physicians in early and late-stage clinical development to execute on biomarker strategies in clinical trials.
  • Write memos, final reports, and publications summarizing data, and write/update lab SOPs.
  • Serve as a subject matter expert in mass spectrometry-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations, and regulatory affairs.

Requirements

  • BA/MS/PhD in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.) or Chemistry.
  • A minimum of 5 years post Ph.D. in a related discipline (e.g., analytical chemistry, biochemistry, etc.).
  • A minimum of 2 years of hands-on direct experience in mass spectrometry-based assay development for proteins in tissues.
  • Extensive experience and knowledge in Liquid Chromatography coupled with Mass Spectrometry for quantitative assessments of peptides and proteins.
  • Significant experience in the handling of biofluids (Plasma, Serum, CSF, etc.) for quantitative targeted analysis of small molecules, peptides, and proteins.
  • Extensive experience using sample preparation methods routinely employed prior to LC/MS (e.g., solid-phase extraction, protein precipitation, immunoaffinity techniques).
  • Strong interpersonal, verbal and written communication skills.
  • Motivated and able to work independently.
  • Ability to execute within a matrixed organization and collaborate with cross-functional teams.
  • Expertise in preparing FFPE tissue for the quantitation of peptides and proteins by LC/MS.

Nice-to-haves

  • Broad knowledge of the drug development process and translational medicine.
  • Use of high-resolution mass spectrometry for the analysis of proteins and peptides.
  • Hands-on experience in clinical development/operation or managing the implementation of biomarker assays in support of drug development.
  • Experience with low flow chromatography.

Benefits

  • Bonus eligibility
  • Long term incentive if applicable
  • Health care and other insurance benefits (for employee and family)
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Sick days
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