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    Investigator/Principal Investigator - Collegeville, United States - GlaxoSmithKline

    GlaxoSmithKline
    GlaxoSmithKline Collegeville, United States

    1 week ago

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    Description

    Site Name:
    USA - Pennsylvania - Upper Providence

    Posted Date:
    Mar

    If you are looking for an exciting opportunity to make a difference in the lives of patients by applying integrated biopharmaceutics / predict first mechanistic modeling 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/Principal

    Investigator, Biopharmaceutics to join the US Biopharmaceutics group within Drug Product 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 and biologics) developed within GSKs Pharmaceutical portfolio.

    The successful candidate will utilize his/her experience in

    biopharmaceutics/modeling,

    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.

    Working in a dynamic, multidisciplinary environment, the candidate will be part of a team developing mechanistic models to predict in-vivo performance (pharmacokinetics) of sterile drug products (e.g., long-acting injectables, biologics).

    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).

    Collaborating with partners across MDS 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 in-silico (digital) mechanistic models to enable science-based predictions of in-vivo performance to support sterile drug product design (e.g., long-acting injectables, biologics).

    Using engineering, chemical, biological and materials science knowledge to postulate mechanisms for

    physicochemical/biological

    processes and developing/modifying existing mathematical models to describe those mechanisms.
    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.

    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 sections of internal and external reports. Presenting effectively to internal GSK forums, 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 to ensure high quality and traceable work.
    Collaborating with project teams to undertake formal risk assessments, root cause analyses and

    investigations.
    Why you?

    Basic Qualifications:
    We are looking for professionals with these required skills to achieve our goals:
    PhD in Pharmaceutics, Chemical Engineering, or related science fields .
    Masters in Pharmaceutics, Chemical Engineering, or related science degree with 5+ years of experience .
    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, SimBiology, Python) and application to product design across dosage forms (e.g., oral, long-acting injectable, implants and biologics).

    Experience in mechanism-based mathematical modeling techniques, and using complex, system level models of biological systems.

    Experience in in-vitro biorelevant measurements for oral biopharmaceutics (e.g., solubility/ dissolution, IDR, transfer models, TIM-1), in-vitro release methods for long-acting injectables and implants, SCISSOR model for subcutaneous modality.


    Preferred Qualifications:
    If you have the following characteristics, it would be a plus:
    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

    pharmacokinetics/performance

    of long-acting injectables, 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.
    Experience in identifying, developing, and applying innovative solutions to scientific and technological problems faced in systems modeling.

    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 experience in formulation design across dosage forms.
    Demonstrated effective interpersonal, communications and negotiation skills. Logical and independent thinking.
    Managing and delivering execution across multiple disciplines and projects.
    Experience with technical risk assessments (FMEA) and control strategy development. Good knowledge of QbD as presented in regulatory dossiers. Experience conducting root cause analyses and investigations.
    #LI-GSK
    Please visit

    GSK US Benefits Summary

    t o learn more about the comprehensive benefits program GSK offers US employees.
    Why Us?

    GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organization where people can thrive.

    Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

    Our success absolutely depends on our people.

    While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive.

    We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

    Were committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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.

    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 GSKs compliance to all federal and state US Transparency requirements.

    For more information, please visit GSKs Transparency Reporting

    For the Record

    site.

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