Investigator (Modeling & Simulation), Open to flexible working
As the Investigator (Modeling & Simulation) you will implement System Modeling (Simulation) directly on key projects to increase fundamental understanding and greatly reduce labor, materials and time required to identify commercial Drug Substance processes. As part of your role you will upskill project team members to expand the use of simulation and work with internal and external experts to development /maintain core simulation software platforms. You will also champion integration of new ways of working into existing QbD work flows (e.g. Process Design, Control Strategy Identification, Risk Assessment), regulatory filing strategies and life cycle planning.
- As part of a matrix Drug Substance project team, use System Modeling to efficiency deliver priority team objectives including but not limited to Process Design, quantitative Risk Assessment, Identification of Critical Process Parameters / Design Space and implementation of advanced process controls.
- Use engineering, chemical or materials science knowledge to postulate mechanisms for physiochemical processes and develop or modify existing mathematical models to describes those mechanisms.
- Perform or direct experimentation and analysis (e.g. chromatography, PAT, physical properties testing) required to develop (e.g. parameter fitting) and verify system models.
- Translate mathematical models to computer models using software platforms (e.g. gPROMS, Aspen and Dynochem) or by writing custom programs (Using Matlab, Python, etc.)
- Development and maintain key system modeling platforms. Leverage external expertise and funding through pre-competitive alliances (e.g. System base Pharmaceutics)
- Provide or coordinate training and real-time support to expand the use of system modeling (simulation) across PDS, BPDS and PSC.
- Work closely with the QbD and DoE communities, Regulatory and other experts to integrate system modeling (Simulation) into QbD process development.
- Work closely with Statistical Science 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 modeling techniques through publications, conferences and academic and precompetitive collaborations
- Advocate and comply with GMP requirements for recording experiments and associated data and writing modeling sports including scientific review and data checking.
- Comply with requirements of Good Manufacturing Practice, Safety, Quality for the Patient and GSK policies and procedures (sites and department).
- Provide input to budget decisions, recommend capital purchases of software supporting modeling and
- As a member of a project team, provide critical support outside area of expertise if required to make sure projects meet development timelines.
Applicants are asked to demonstrate in their application how they meet the above criteria in order to be successful for interview selection.
CLOSING DATE for application: Friday 1st of November 2019 (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.
- Relevant experience of working in a highly regulated technical industry.
- Relevant vocational / higher level qualification in a relevant discipline (eg; An MSc or PhD in Chemical Engineering or equivalent experience with an emphasis on development and implementation of mechanistic mathematical models).
- Ability to translate mathematical models into computer programs (using Matlab, Python, gPROMS or similar software tools).
- An understanding of statistical science and related software tools that enable sound experimental design and interpretation of models.
- Good lab skills including the ability to independently design and execute experimental plans and perform any related analytical testing.
- Experience with engineering software such as Dynochem, Aspen or gPROMS.
- Understands and complies with GMP requirements including; data integrity and model validation / maintenance.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. We employ over 100,000 people globally. For more information on GSK please refer to our website: www.gsk.com
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