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Johnson & Johnson Innovative Medicine · 1 day ago

Principal Scientist, Biopharmaceutics

Malvern, PA

Full-time

Hybrid

Senior Level, Lead/Staff

5+ years exp

Johnson & Johnson Innovative Medicine is a leader in healthcare innovation focused on developing treatments and cures for complex diseases. The Principal Scientist in Biopharmaceutics will lead scientific strategies and experimental programs to advance biologics from early development through clinical phases, focusing on subcutaneous delivery platforms and pharmacokinetic modeling.

Pharmaceuticals

Responsibilities

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

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

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

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

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

Represent Biopharmaceutics on Chemistry, Manufacturing and Controls (CMC) and development teams

Mentor junior scientists and promote technical excellence across the organization

Author technical reports and contribute to IND/CTA/BLA/MAA submissions

Ensure compliance with global regulatory requirements and internal quality standards

Qualification

PharmacokineticsBiopharmaceuticsBiologics developmentPK modelingFormulation sciencePhoenix WinNonlinSimcypPythonRRegulatory submissionsCombination product developmentCommunicationOrganizational skillsCreative mindsetCollaboration

Required

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

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

The ability to collaborate effectively with cross-functional teams is required

Preferred

Experience with R and Python for custom modeling as well as advanced data analysis and visualizations is preferred

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