Analytical Development Scientific Integrator, Biotherapeutics

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