Principal Scientist, Biopharmaceutics Full-time

Principal Scientist, Biopharmaceutics

Johnson & Johnson Innovative Medicine R&D is recruiting for a Principal Scientist, Biopharmaceutics. This position is a hybrid role and will be located in Malvern, PA.

We are seeking a highly motivated Principal Scientist to join the Biopharmaceutics team within the Drug Product Development and Delivery (DPD&D) organization, focusing on biologics biopharmaceutics (monoclonal antibodies, bispecifics, antibody drug conjugates (ADCs), fusion proteins, and other therapeutic proteins). This role will lead scientific strategies and experimental programs to enable subcutaneous (SC) delivery platforms, bridging strategies (IV-to-SC and SC-to-SC), combination product development, and targeted delivery approaches. This individual will apply expertise in pharmacokinetics, biopharmaceutics, and formulation science to advance biologics from early development through clinical phases.

Principal Responsibilities:

• Bioavailability and Bridging Strategies:
• Design and execute studies to understand SC absorption and bioavailability of biologics.
• Develop IV-to-SC and SC-to-SC bridging strategies to support clinical development and regulatory submissions.
• Analyze prior knowledge and integrate internal and external data to generate new insights on the impact, or lack thereof, of quality attribute changes (glycosylation, charge variants, PTMs, etc.) on pharmacokinetic (PK), efficacy, safety resulting from process changes, to inform biocomparability assessments.
• Design and conduct targeted in vitro and preclinical studies to produce primary data that provide additional evidence for biocomparability assessments.
• Drive innovation in large volume, high concentration, and novel non-aqueous suspension formulations to enable high dose SC delivery.
• Develop in vitro and in silico tools and models to support formulation selection and clinical translation.
• Combination Product Development:
• Collaborate with Drug Delivery Systems (DDS) teams in DPD&D to enable robust drug-device integration for SC delivery.
• Define clinically relevant in-use conditions and controls for combination products.
• Pharmacokinetic Modeling and Simulation:
• Apply PK modeling to optimize dosing regimens and assess whether alternative dosing strategies can achieve comparable PK profiles, supporting formulation and drug product presentation decisions.
• Use translational modeling to evaluate formulation impact on PK and support bridging strategies.
• Targeted Delivery:
• Advance strategies for targeted delivery, including crossing the blood-brain barrier (BBB), intratumoral administration, and other innovative approaches.
• Develop in vitro and in silico models to predict and optimize targeted delivery approaches.
• Clinically Relevant Controls:
• Establish science and risk-based control strategies that link quality attributes to potential impact on safety, efficacy, immunogenicity.
• Leverage prior knowledge and predictive models to scientifically justify control limits, ensuring robust design space that meets regulatory requirements and patient needs.
• Cross-Functional Leadership:
• Represent Biopharmaceutics on Chemistry, Manufacturing and Controls (CMC) and development teams.
• Mentor junior scientists and promote technical excellence across the organization.
• Regulatory and Documentation:
• Author technical reports and contribute to IND/CTA/BLA/MAA submissions.
• Ensure compliance with global regulatory requirements and internal quality standards.

Qualifications:

• A minimum of a Ph.D. in Pharmaceutical Sciences (Pharmacokinetics, Biopharmaceutics), Chemical Engineering or related discipline is required.
• A minimum of 5 years of experience in biologics development is required.
• Experience in pharmacokinetic (PK) modeling and bridging strategies required.
• Proficiency in PK modeling of biologics using tools such as Phoenix WinNonlin, Simcyp, PK‑Sim, NONMEM, and GastroPlus is required.
• Experience with R and Python for custom modeling as well as advanced data analysis and visualizations is preferred.
• Deep understanding of ADME of therapeutic proteins (mAbs, bispecifics, ADCs, etc.) is required.
• Experience with model-informed approaches (PK/PBPK) to characterize absorption and exposure of biologics and support formulation and drug product presentation decisions is required.
• Familiarity with in-vitro in-vivo correlation (IVIVC) or IVIIVC-like approaches for assessing formulation impact on absorption and exposure for novel formulations and novel delivery systems is preferred.
• Understanding of biologics formulation principles and their impact on PK is preferred.
• Prior involvement with regulatory submissions for biologics is preferred.
• Experience with device-drug integration and combination product development is preferred.
• Must have excellent verbal and written communication skills.
• Must have strong organizational skills.
• Must be creative with a strong scientific mindset.
• The ability to collaborate effectively with cross-functional teams is required.

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 candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.