Scientific Leader, Biopharmaceutics
Site Name: USA - Pennsylvania - Upper Providence Posted Date: May 27 2021 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 drug product design and 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, Biopharmaceutics to join the US Biopharmaceutics group within Pharmaceutical 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) 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. Key Responsibilities: Applying biopharmaceutics knowledge across projects to support integrated product design, drug delivery and targeting, innovative manufacturing processes, and smart bioavailability and bioequivalency 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). 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 MST 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, transfer models for oral; in-vitro release methods for long-acting injectables, implants) across projects and collaborating with partners (e.g. Materials Science, CMC Analytical) 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 Pharmaceutical Development, Chemical Development, Process Engineering and Analytics and CMC Analytical 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. 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 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 sections 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 for all work. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD with five years of experience in the field of biopharmaceutics, drug absorption/ pharmacokinetics, PBPK modeling, in-silico platforms and/or drug delivery. 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, pediatric, long-acting injectable, implants). Experience in in-vitro biorelevant measurements (e.g. solubility/dissolution, IDR, transfer models) for oral biopharmaceutics, and/or in-vitro release methods for long-acting injectables and implants. 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 with formulation design across dosage forms. 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. Demonstrated experience in understanding biopharmaceutics across dosage forms including oral, pediatric, sterile, long acting injectable and/or implant products using QbD principles. 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. Has track record of moving projects/functions forward successfully Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. 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