Bioanalytical Scientific Manager (US)

UCBCambridge, MA
Hybrid

About The Position

This is an exciting opportunity where you will contribute to the design and execution of bioanalytical strategies supporting biologics, small molecule and/or gene therapy programs. You will work across assay development for pharmacokinetics, immunogenicity, and (exploratory) biomarkers, ensuring high scientific quality and regulatory compliance as required. The role offers strong exposure to multidisciplinary teams and the opportunity for strategic bioanalytical leadership.

Requirements

  • Master’s or PhD in life sciences or related scientific discipline
  • Knowledge of regulatory requirements for bioanalytical methods and data quality
  • Ability to translate project needs and strategies (pharmacokinetics, immunogenicity, and biomarkers) into a bioanalytical strategy.
  • Strong collaboration skills in cross-functional and matrix environments
  • Proactive mindset with strong problem-solving and scientific reasoning

Responsibilities

  • Design and support bioanalytical strategies across pharmacokinetics, immunogenicity, and biomarkers
  • Collaborate with teams to translate study goals into analytical strategies
  • Oversee internal and external bioanalytical activities ensuring quality and timelines
  • Contribute to regulatory documentation and health authority interactions
  • Support assay development, validation, and scientific interpretation of data
  • Identify risks and propose solutions to ensure study and project progression
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