Investigator, Biopharmaceutics, Drug Product Development

Job description

Nombre del sítio: UK - Hertfordshire - Ware RD
Fecha de publicación: Feb 28 2024

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/Principal Investigator, Biopharmaceutics to join the UK 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) 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 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 plans for in-vitro biorelevant measurements (e.g., solubility/dissolution, IDR, permeability, transfer models for oral; in-vitro release methods for long-acting injectables, implants) 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 post transfer to manufacturing 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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

·  BSc in an appropriate discipline, with relevant scientific experience and capabilities.
·  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 for oral biopharmaceutics (e.g., solubility/ dissolution, IDR, transfer models, TIM-1), 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 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/modeling with formulation design across dosage forms.
·  Demonstrated experience in understanding biopharmaceutics/in-vivo performance across dosage forms including oral, pediatric, long acting injectables and/or implant 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 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.

Closing Date for Applications: Monday 18th March 2024 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert. 
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.  If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Como empresa impulsada por nuestros valores de enfoque al paciente, transparencia, respeto e integridad, sabemos que la inclusión y la diversidad son esenciales para que podamos tener éxito. Queremos que todos nuestros colegas prosperen en GSK, brindando sus experiencias únicas, asegurándonos de que se sientan bien y que sigan creciendo en sus carreras.  Como candidato para un papel, queremos que usted se sienta de la misma manera.

Creemos en una cultura de trabajo ágil para todos nuestros roles. Si la flexibilidad es importante para usted, lo alentamos a explorar con nuestro equipo de contratación cuáles son las oportunidades.

No dude en ponerse en contacto con nosotros si desea analizar cualquier ajuste a nuestro proceso que pueda ayudarlo a demostrar sus fortalezas y capacidades.  Puede llamarnos al 0808 234 4391 o enviar un correo electrónico Ukdiversity.recruitment@gsk.com .   

A medida que lo solicite, le pediremos que comparta alguna información personal que sea voluntaria. Esto se utilizará para ayudarnos a comprender qué tan bien estamos haciendo frente a nuestras ambiciones de inclusión y diversidad. Realmente lo agradeceríamos si pudiera tomarse unos momentos para completarlo. Tenga la seguridad de que los gerentes de contratación no tienen acceso a esta información, no se utiliza en ninguna parte del proceso de selección y trataremos su información de forma confidencial y la utilizaremos de forma anónima.