Are you looking for an exciting opportunity to make a global impact in process modeling? If so, we have the right opportunity for you!

As an Investigator, Modeling and Simulation in the US Process Engineering & Analytics – Sterile NCE Drug Product & Biopharma drug substance group you will be responsible for:

• Developing and implementing hybrid/mechanistic process models to accelerate development, increase fundamental understanding, improve risk assessment, and deliver more robust processes for biopharmaceutical products.
• Developing and implementing chemometric process models to support process monitoring and control activities for biopharmaceutical manufacturing.
• Implementing modeling and simulation directly on key projects to increase fundamental understanding and greatly reduce labor, materials and time required to identify commercial Biopharmaceutical processes.
• Upskilling project team members to expand the use of modeling and simulation and work with internal and external experts to develop/maintain core simulation software platforms.
• Championing integration of new ways of working into existing Quality by Design workflows (e.g., Process Design, Control Strategy Identification, Risk Assessment), regulatory filing strategies and life cycle planning.
• Use engineering, biochemical, and biological knowledge to postulate mechanisms for biological processes and develop or modify existing mathematical models to describe those mechanisms.
• Translate chemometric and mechanistic models to computer models using software platforms (e.g. Unscrambler/Process Pulse, SIMCA, gPROMS, ASPEN and Dynochem) or by writing custom programs (Using Matlab, Python, C++ etc.)
• Develop and maintain key chemometric and mechanistic modelling platforms.
• Provide or coordinate training and real-time support to expand the use of chemometrics and mechanistic modeling (simulation) across business modalities.
• 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).

Why you?

Basic Qualifications:

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

• Master's Degree in Chemical or Biochemical Engineering or a related subject with emphasis on process modeling and advanced process control.
• Experience with ability to translate mathematical models into computer programs using Matlab, Python, gPROMS or similar software tools.
• Proven track record of scientific publications in the field of process modelling/advanced process control
• Experience with a broad range of mechanistic/hybrid/chemometric modelling techniques

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• PhD in Chemical or Biochemical Engineering or a related subject with emphasis on process modeling and advanced process control.
• Experience in the use of advanced process modeling techniques in an industrial environment
• Familiarity with machine learning methods (SVM, ANN, Bayesian modeling) and chemometric models (PCA/PLS etc.)
• Experience using data analytics and modeling tools for chemical and/or biochemical processes.
• Industrial experience in one or more of the following areas: biopharmaceuticals development; product industrialization and manufacturing.
• Programming experience using languages such as Matlab, Python, R or C
• Demonstrated ability to independently design and execute work plans and experimentation to support models development.
• Good interpersonal, organizational and communication skills.
• Familiarity with Quality by Design concepts, their application and ICH Q8/Q9/Q10 guidelines.
• Experience in the definition of data and informatics requirements for digital platforms supporting modeling.
• Ability to multi-task and manage workload independently.
• Ability to work within a team and communicate effectively.
• Mastery of mainstream chemometric techniques (multivariate classification, calibration, pattern recognition, PCA/PLS) and familiarity with design of experiments concepts and methods.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

• LI-GSK

#CMCDevelopmentGSK

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