Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Apr 19 2024
The Investigator, Modelling and Simulation, will be part of a team developing advanced modelling approaches to accelerate development, increase fundamental understanding, improve risk assessment, and deliver more robust processes for sterile drug products and large molecule drug substance. This includes the application of mechanistic modelling (particularly System Modelling), data driven modelling, and hybrid methodologies in process design, control strategy definition, and advanced process monitoring & control.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include the following:
- As part of matrix project teams, develop and deploy mechanistic, data driven, and hybrid modelling solutions for sterile drug products and large molecule drug substance.
- Use engineering, chemical, biological, and materials science knowledge to postulate mechanisms for physiochemical processes and develop or modify existing mathematical models to describes those mechanisms.
- Design experimentation and analysis required to develop and verify system models.
- Develop product performance models. Build systems-based understanding of sterile drug products integrating materials science understanding, process, and product performance models.
- Translate mathematical models to computer models using software platforms (e.g., gPROMS) or by writing custom programs.
- Understand the requirements to develop model-based soft sensors and model predictive control.
- Work closely with the Quality, Regulatory and other experts to integrate process modelling approaches into QbD process development for small molecule drug substance.
- Work closely with Statistical Sciences to develop the best in-silico experimental design and to engage them to assess model uncertainty and model predictive confidence limits.
- Stay current with new modelling techniques through publications, conferences and academic and precompetitive collaborations.
- Track progress against deliverables and maintain a communication plan with stakeholders and partners across departments.
- Advocate and comply with GMP requirements for recording experiments and associated data, and writing reports, including scientific review and data checking.
- Comply with the requirements of Quality, Safety, and GSK policies and procedures and ensure that GSK intellectual property is protected.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Ph.D. in Chemical Engineering, Chemistry, Materials Sciences with an emphasis on development and implementation of mechanistic mathematical models and / or data driven modelling approaches for sterile drug products or large molecule drug substance operations.
- Experience translating mathematical models into computer programs using MATLAB, Python, or similar software tools.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- An understanding of statistical science and related software tools that enable sound experimental design and interpretation of models.
- 2+ years of previous industry or post-doctoral experience
- Publications in peer reviewed journals.
- Experience in system modelling and platforms such as gPROMs.
- Understanding of in vitro and in vivo product performance modelling.
- Prior experience working on model-based soft sensors and development of digital twins.
- Good interpersonal, organizational and communications skills.
*LI-GSK
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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