Principal Scientist, Biopharmaceutics

About the role

Johnson & Johnson is a global healthcare company dedicated to improving health through innovative medicine and medical technology. The Biopharmaceutics team in the Drug Product Development and Delivery (DPD&D) organization is seeking a Principal Scientist to develop and validate in vitro-in vivo correlation (IVIVC) tools and models, support bridging strategies, and drive innovation in biologics delivery.

Responsibilities

• Design and execute studies to characterize subcutaneous (SC) absorption and bioavailability of biologics.
• Develop intravenous-to-subcutaneous (IV-to-SC) and SC-to-SC bridging strategies to support clinical development and regulatory submissions.
• Support biocomparability assessments for Drug Substance (DS) or Drug Product (DP) changes.
• Drive innovation in large-volume, high viscosity, high-concentration, novel formulations and delivery devices to enable high dose SC delivery.
• Collaborate with Drug Delivery Systems (DDS) team on combination product development.
• Develop in vitro and in silico tools and models to support formulation selection and clinical translation.
• Apply pharmacokinetic (PK) modeling to support formulation and drug product presentation decision and bridging strategies.
• Advance targeted delivery strategies, including blood-brain barrier (BBB), intratumoral, and other innovative delivery approaches, supported by development of relevant in vitro and in silico models.
• Use prior knowledge and predictive tools to define control strategies and design space that are scientifically justified, regulatory-aligned, and patient-focused.
• Represent Biopharmaceutics on product development teams and support the biologics portfolio.
• Mentor and promote technical excellence across the organization.
• Author technical reports, publications, and regulatory submissions.

Qualifications

• A minimum of a Ph.D. in Pharmaceutical Sciences or Chemical Engineering, or a PharmD in Pharmacy or a related discipline is required.
• A minimum of 3 years of experience in biologics product development is required.
• Experience applying PK, PBPK, and other model-informed approaches to support IV-SC, SC-SC bridging strategies and inform formulation and drug product presentation strategies is preferred.
• Familiarity with IVIVC or IVIIVC-like approaches to assess the impact of formulation or delivery systems on absorption and exposure is preferred.
• Understanding of biologics formulation principles and their relevance to PK and clinical performance is preferred.
• Experience with drug-device integration and bridging strategies for combination products is preferred.
• Experience with biocomparability assessments is preferred.
• Excellent verbal and written communication skills.
• Strong organizational skills.
• Strong scientific mindset and creativity.
• The ability to collaborate effectively with cross-functional teams is required.