Principal Scientist, Biopharmaceutics

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at & 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 onthe 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 PKSim 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.

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