Principal Scientist, Biopharmaceutics

Principal Scientist, Biopharmaceutics

Location:

Malvern, Pennsylvania, United States of America (Hybrid; may work remotely).

Job Function:
Discovery & Pre-Clinical/Clinical Development | Job Sub Function:
Biotherapeutics R&D | Job Category:
Scientific/Technology

Johnson&Johnson Innovative Medicine R&D is recruiting for a Principal Scientist in the Biopharmaceutics team, focusing on biologics biopharmaceutics (monoclonal antibodies, multispecifics, ADCs, fusion proteins, and other therapeutic protein modalities). The role leads scientific strategies and experimental programs on bridging approaches, drug delivery platforms, combination products, and targeted delivery to advance biologics from early development through clinical phases.

• Design and execute studies to characterize SC absorption and bioavailability of biologics, including development and validation of in vitro‑in vivo correlation (IVIVC) tools and models.
• 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 the 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 decisions 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.

• A minimum of a Ph.D. in Pharmaceutical Sciences or Chemical Engineering, a PharmD in Pharmacy, or a related discipline.
• At least 3 years of experience in biologics product development.
• 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.
• Familiarity with IVIVC or IVIIVC‑like approaches to assess the impact of formulation or delivery systems on absorption and exposure.
• Understanding of biologics formulation principles and their relevance to PK and clinical performance.
• Experience with drug‑device integration and bridging strategies for combination products.
• Experience with biocomparability assessments.
• Excellent verbal and written communication skills.
• Strong organizational skills and a creative, scientific mindset.
• Ability to collaborate effectively with cross‑functional teams.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified veterans and individuals with disabilities. If you have a disability and would like to request an accommodation, please contact the Employee Health Support Center.