Analytical Development Scientific Integrator, Biotherapeutics Job at Johnson & Johnson, Malvern, PA

  • Johnson & Johnson
  • Malvern, PA

Job Description

Johnson & Johnson seeks a Principal Scientist to lead analytical development teams for biopharmaceutical programs in early-stage clinical development. The role involves providing strategic and technical leadership on cross-functional CMC teams, managing analytical control strategies, and ensuring regulatory compliance for monoclonal antibodies and related protein therapeutics.

Responsibilities

  • Lead cross-functional analytical teams and represent Analytical Development on CMC project teams
  • Direct critical quality attribute assessment, control strategy, and specification development for programs
  • Oversee analytical review at governance meetings and manage project risk mitigation
  • Author and submit regulatory documents to health authorities and address agency questions
  • Communicate project status, resource needs, and issues to senior management

Requirements

  • Master's degree in Analytical Chemistry, Biochemistry, or related discipline with 8+ years biopharmaceutical development experience
  • PhD in relevant field with 3+ years biopharmaceutical development experience preferred
  • 2+ years cross-functional CMC or analytical team leadership in matrix environment
  • Knowledge of biotherapeutic analytical strategy, protein characterization, and potency assays
  • Experience authoring and reviewing CMC sections of clinical trial applications and regulatory submissions
  • Strong leadership, communication, and stakeholder collaboration skills
  • Protein conjugate development experience is a plus

Compensation: $117,000–$201,250 base

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