Malvern, Pennsylvania, United States of America, United States of America
Hybrid
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Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Malvern, Pennsylvania, United States of AmericaJob Description:
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 https://www.jnj.com/innovative-medicine
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 in the Drug Product Development and Delivery (DPD&D) organization, focusing on biologics biopharmaceutics (monoclonal antibodies, multispecifics, antibody drug conjugates (ADCs), fusion proteins, and other therapeutic protein modalities). This role will lead scientific strategies and experimental programs on bridging approaches (e.g., IV-to-SC and SC-to-SC), drug delivery platforms, combination products, and targeted delivery. This individual will apply expertise in pharmacokinetics, biopharmaceutics, and formulation science to advance biologics from early development through clinical phases.
Principal Responsibilities:
Design and execute studies to characterize SC absorption and bioavailability of biologics including the 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 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.
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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific ResearchWant to know if this job is worth applying to?