Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Feb 4 2020
As a Chemometrics Investigator in the US Process Engineering & Analytics - Sterile NCE Drug Product & Biopharm group you will be responsible for:
- Developing and implementing chemometric models from PAT data (e.g. process time series data, spectroscopy etc.), materials data and/or process data to accelerate development, increase fundamental understanding, improve risk assessment and deliver more robust processes, products and regulatory filings.
- Upskilling project team members to expand the use of chemometric models and work with internal and external experts to development /maintain core simulation software platforms.
- Championing 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- As part of a matrix Drug Substance or Drug Product project team, use chemometric 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.
- Develop chemometric models to extract relevant information from process time series data and other PAT technologies to implement approaches for process understanding, monitoring and control.
- Develop chemometric models from materials and process databases to increase understanding and greatly reduce labor, materials and time required to identify commercial processes.
- Provide guidance on the generation of relevant experiments for the development of chemometric models.
- Translate chemometric models using relevant software platforms (e.g. SIMCA, SIMCA-online, Unscrumbler, Statistica) or by writing custom programs (Using Matlab, Python, etc.).
- Develop and maintain key chemometric modeling platforms.
- Provide or coordinate training and real-time support to expand the use of chemometrics modeling across PDS, BPDS and PSC.
- Contribute to the definition of the modeling and PAT strategy for new products and processes and contribute to the evolution of the QbD framework to meet regulatory expectations.
- Stay current with new modeling techniques through publications, conferences and academic and precompetitive collaborations
- Advocate and comply with Good Manufacturing Practice (GMP) requirements for recording experiments and associated data and writing reports including scientific review and data checking.
- Comply with requirements of GMP, 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 monitoring activities.
- As a member of a project team, provide critical support outside area of expertise if required to make sure projects meet development timelines.
- PhD in Chemometrics, Industrial Engineering or a related subject with emphasis on data analytics and process modeling.
- Ability to multi-task and manage workload independently
- Ability to work within a team and communicate effectively
- Demonstrated knowledge of a broad range of chemometrics techniques
- Mastery of mainstream chemometric techniques (multivariate classification, calibration, pattern recognition, PCA/PLS) and familiarity with design of experiments concepts and methods.
- Experience in the use of advanced chemometric methods for process modeling (MSPC, MCR) and 'data wrangling' for signal processing and feature extraction.
- Familiarity with other data driven machine learning methods (SVM, ANN, Bayesian modeling) or the application of hybrid empirical/mechanistic modeling.
- Experience using data analytics and modeling tools for chemical and/or biochemical processes.
- Industrial experience in one or more of the following areas: i) continuous processes; ii) drug substance development; iii) biopharmaceuticals development; iv) product industrialisation 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.
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