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Reference #: 389551 Site Name: USA - Pennsylvania - Upper Providence Posted Date: Feb 15 2024

Job Description

If you are looking for an exciting scientific leadership opportunity to make a difference in the lives of patients by applying integrated biopharmaceutics to support patient focused product development to help people do more, feel better and live longer, this might just be the role for you.

We are looking for an experienced Scientific Leader/Associate Director, Biopharmaceutics to join the US Biopharmaceutics group within Drug Product Development. In this role, you will continue to build biopharmaceutics capability and scientific understanding, and interact with project teams to support the design of all new drug products (including oral, long-acting injectables, implants and biologics) developed within GSK's Pharmaceutical portfolio.  The successful candidate will utilize his/her substantial experience and expertise in biopharmaceutics, and use biopharmaceutics knowledge created using integrated in-vivo, in-vitro and in-silico (physiologically based pharmacokinetic/ biopharmaceutics modelling) tools to design and develop the most suitable drug product that is fit for the patient and meets the development timelines.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Applying biopharmaceutics knowledge across projects to support integrated product design, drug delivery and targeting, innovative manufacturing processes, and smart bioavailability and bioequivalence studies, where applicable. Developing projects/platform specific biopharmaceutics knowledge (integrated in-vivo, in-vitro, and in-silico understanding) to support the design and development of exceptional patient focused drug products (e.g., oral, long-acting injectables, implants and biologics). Providing world class leadership of biopharmaceutics to support exceptional formulation design and development of innovative platforms to ensure that we remain world leading in the science to support both current and future portfolio. Collaborating with partners across MDS and IVIVT to build mechanistic understanding of absorption/biopharmaceutics (through application of PBPK modeling, e.g., Gastroplus, Simcyp) and applying this fundamental understanding around product performance, biology, and PK to design the best value-added platforms and products. Developing plans for in-vitro biorelevant measurements (e.g., solubility/dissolution, IDR, permeability, transfer models for oral; in-vitro release methods for long-acting injectables and implants; SCISSOR model for subcutaneous modality) across projects and collaborating with partners (e.g., Materials Science, Analytical Development) to generate input data for modelling in-vivo product performance. Developing in-vitro and in-silico (digital) models to enable mechanistic, science-based predictions of in-vivo pediatric behavior of drugs to support pediatric product design. Working with team members in Drug Product Development, Drug Substance Development, Process Engineering and Analytics and Analytical Development groups to support development of clinically relevant control strategies (e.g., applying physiologically based biopharmaceutics modeling) across projects for global filings. Providing biopharmaceutics focused technical support as needed to established commercial projects when such support is endorsed and prioritized by CMC Board. Designing and executing modeling and/or experimental studies that influence project direction in line with QbD approaches. Proactively engaging and collaborating with cross-functional scientists to solve problems. Demonstrating networking and influencing skills through interactions across departments and divisions.

Additional responsibilities include: Preparing oral or written summaries of results with interpretation for project work. Writing specific technical sectio s of internal and external reports. Presenting effectively to internal GSK forums, governance reviews and external meetings. Keeping manager and CMC/MPD Leader informed of progress and activities. Independently preparing and communicating recommendations for next steps to members of own team or matrix teams. Being responsible for sharing relevant scientific information from internal and external meetings with appropriate colleagues. Demonstrating timely and reliable recording of data/results in suitable systems in accordance with company policy and legal requirements. Performing data management and data stewardship to ensure high quality and traceable work.

Why you? Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals: PhD with 5+ years of experience in the field of biopharmaceutics, drug absorption/ pharmacokinetics, PBPK modeling, in-silico platforms and/or drug delivery of small molecules and/or biologics Experience in biopharmaceutics/drug absorption, related tools (in-vivo, in-vitro, in-silico) and product design and development. Experience in mechanistic PBPK modelling (e.g., Gastroplus, Simcyp), in-silico platforms (e.g., MATLAB, gPROMS) and application to product design across dosage forms (e.g., oral, long-acting injectable, implants and biologics). Experience in in-vitro biorelevant measurements, e.g., solubility/dissolution, IDR, transfer models for oral biopharmaceutics, in-vitro release methods for long-acting injectables and implants, SCISSOR model for subcutaneous modality. Experience in regulatory biopharmaceutics requirements and drug development process.

Preferred Qualifications: If you have the following characteristics, it would be a plus: Recognized by peers and sought out as an expert in his/her scientific field or technical area. General knowledge of preclinical and clinical development disciplines including DMPK, Safety, Clinical Pharmacology, etc. and integration of biopharmaceutics/modeling with formulation design across dosage forms. Integrated understanding of the subcutaneous bioavailability/performance of biologics (e.g., monoclonal antibodies) and predictive models (in-vitro, in-silico). Demonstrated experience in understanding biopharmaceutics/in-vivo performance across dosage forms including oral, long acting injectables, implants, and/or subcutaneous biologic products. Excellent written and oral communication skills and the ability to interact effectively with scientists in other disciplines with a positive and collaborative attitude. Demonstrated collaborative behaviors working in a matrix environment and working across functions/disciplines. Understanding of late-stage product development. Understanding of regulatory requirements for change management for a global file. Demonstrated fundamental knowledge of the literature in own scientific discipline and/or biopharmaceutics. Demonstrated experience in formulation design across dosage forms. Demonstrated effective interpersonal, communications and negotiation skills. Logical and independent thinking. Managing, prioritizing, and delivering execution across multiple disciplines and projects. Has track record of moving projects/function forward successfully in own discipline.

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