Principal Scientist, Early Development ADSI (Biotherapeutics)

Location: Malvern, Pennsylvania, United States of America

Company

Johnson & Johnson develops innovative medicines and MedTech solutions across healthcare.

What you will do

• Provide strategic and technical leadership in analytical development.
• Lead a cross-functional scientific team representing analytical development sub-functions.
• Represent analytical development on CMC teams and oversee project deliverables.
• Lead critical quality attribute assessments, analytical control strategies, and product specifications.
• Review programs at governance meetings and prepare complete, consistent regulatory documents.
• Manage project risks, mitigation strategies, resources, budgets, issues, and stakeholder communication.

Requirements

• Master’s degree in Analytical Chemistry, Biochemistry, Biological Science, or a related discipline; a Ph.D. is preferred.
• At least 6 years of biopharmaceutical development experience with a Master’s degree, or at least 3 years with a Ph.D.
• Knowledge of biotherapeutic development and analytical strategies, including protein characterization, separation techniques, and biological potency assays.
• Experience authoring and reviewing CMC sections of clinical trial applications, including INDs and IMPDs, and responding to health authority questions.
• Strong communication, interpersonal, negotiation, leadership, collaboration, and complex-plan execution skills in a matrix environment.

Nice to have

• At least 2 years of experience working on cross-functional CMC teams or analytical sub-teams.
• Ph.D. in Analytical Chemistry, Biochemistry, Biological Science, or a related scientific discipline.

Culture & Benefits

• Inclusive work environment focused on diversity and employee dignity.
• Equal employment opportunity for qualified applicants.
• Interview accommodations are available for applicants with disabilities.