- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Aug 4 2020
Are you looking for a challenging opportunity that allows you to leverage your chemometric and process modeling expertise? If so, this Investigator, Modeler role could be an exciting opportunity to explore.
As a Modeler 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. You will also be responsible for 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. Lastly you will champion the 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.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- PhD in Chemometrics, Industrial Engineering or a related subject with emphasis on data analytics and process modeling.
- Experience with 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.
- Experience using data analytics and modeling tools for chemical and/or biochemical processes.
- Programming experience using languages such as Matlab, Python, R or C
- Experience in the definition of data and informatics requirements for digital platforms supporting modeling.
If you have the following characteristics, it would be a plus:
- Familiarity with other data driven machine learning methods (SVM, ANN, Bayesian modeling) or the application of hybrid empirical/mechanistic modeling.
- Demonstrated knowledge of a broad range of chemometrics techniques
- Ability to multi-task and manage workload independently
- Ability to work within a team and communicate effectively
- 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.
- 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.
Our values and expectationsare 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, rigour 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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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