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Investigator, Biopharmaceutics, Pharmaceutical Development

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
May 15, 2022

View more

Discipline
Other, Other
Job Type
Group Leader/Principal Investigator
Organization Type
Pharma
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Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware Posted Date: May 10 2022 If you are looking for an exciting 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 Investigator, Biopharmaceutics to join the US Biopharmaceutics group within Pharmaceutical Development. In this role, you will interact with project teams and support the design of all new drug products (including oral, long-acting injectables, implants) developed within GSK's Pharmaceutical portfolio. This will be based on 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). Collaborating with partners across MST and IVIVT to build mechanistic understanding of absorption/biopharmaceutics (through use 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 post DG8 when such support is endorsed and prioritized by NPSB. 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 fora, governance reviews and external meetings. 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: BSc in a scientific field Experience in biopharmaceutics/drug absorption and related tools (in-vivo, in-vitro, in-silico). 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. Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD/Masters in the field of biopharmaceutics, drug absorption/pharmacokinetics, PBPK modeling, in-silico platforms and/or drug delivery. 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 experience in formulation design across dosage forms. Customer focused, yet challenging. Demonstrated effective interpersonal, communications and negotiation skills. Logical and independent thinking. Managing and delivering execution across multiple disciplines Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK 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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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