Investigator, Biopharmaceutics, Drug Product Development

Site Name: UK - Hertfordshire - Ware RD
Posted Date: 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.

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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, it’s 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. We’re 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.

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