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Investigator/Principal Investigator

3 months ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time

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 GSK's 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.
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