Biopharm Chemometrics and Process Modeling Expert
Location:
, Pennsylvania
Posted:
September 23, 2017
Reference:
WD107151
Basic qualifications:
• A Masters degree or higher in engineering, chemistry or a related science discipline with a strong mathematical/statistical emphasis.
• A track record of using theoretical and practical knowledge of advanced statistical analysis techniques in problem solving in either chemometrics and/or process modeling. Relevant techniques include; multivariate analysis (MVA), empirical DoE approaches, mechanistic modeling, advanced statistical and process modeling and simulation.
• Basic knowledge of Process analytical technology (PAT)
• Working knowledge of different spectroscopic techniques such as Raman, IR, fluorescence, UV etc

Preferred qualifications:
• An advanced degree (MSc, PhD) in chemometrics, engineering, chemistry or a related science discipline with a strong mathematical/statistical emphasis or relevant transferable experience.
• 1-3 years of experience in either chemometrics and/or process modeling (experience in both preferred)
• Computer science skills, such as experience with numerical computation and/or event driven languages such as MATLAB/R/C/VBAA
• A good understanding of the unit operations and instrumentation used in drug substance and / or drug product development
• Experience with chemometrics software such as SIMCA, The Unscrambler, data extraction tools such as SIPAT
• Hands on experience working in a plant environment in small or large molecule space
• Basic understanding of biopharmaceutical manufacturing process and unit operations.
• Experience with multivariate analysis and multivariate process control
• Experience with process modeling tools to measure process efficiency, throughput, cost-of-goods calculations. Experience with process modeling tools such as SuperPro, BioSolve are preferred
• Experience applying multivariate analysis in root cause analysis and continuous improvement in the pharmaceutical industry or industries with similar type unit operations and customer requirements.
• An understanding of cGMP, validation and regulatory knowledge for pharmaceutical product development, especially Quality by Design principles.
• Demonstrated creativity in devising modeling approaches for new technologies and unit operations.
• Demonstrated ability to independently design and execute work plans.
• Demonstrated effective interpersonal, communications and negotiation skills for a wide variety of audiences, including senior management
• Passionate personality and positive attitude
• Ability to work on multiple tasks/technologies at a given time.
• Strong ability to build relationships
• Demonstrated effective interpersonal, communication, and negotiation skills across internal and external stakeholders and senior managers
• Influential, yet challenging
• Logical and independent thinking

Details:
An exciting new chemometrics and process modeling opportunity exists in the Biopharm workstream of the Advanced Manufacturing Technology (AMT) group. The AMT group was created to deliver GSK's Manufacturing Technology Roadmap with the global objective to transform the way GSK manufacturers its pharmaceutical products over the next 5-10 years. The Biopharm workstream of the AMT group has identified a portfolio of new technology platform opportunities with the potential to transform biopharmaceutical development and manufacturing within GSK. Activities fall into the seek, select, learn, integrate and incubate phase of the Manufacturing Technology Roadmap.
The successful candidate would work with members of the Biopharm-AMT team in two broad areas. The first area is chemometrics modeling whereby the successful candidate will mainly support the process analytical technology (PAT) development efforts for Biopharmaceutical manufacturing occurring in the Biopharm workstream of AMT and more broadly with the Biopharm Process Development organization. The second area is process modeling whereby the successful candidate will assist in developing suitable process models to help assess the impact of new technologies and different ways of working. The assessment of the impact could be on metrics such as Cost-of-Goods, determining throughput and efficiency of the plant manufacturing areas etc. There is an expectation that the candidate will stay connected with the wider modeling community within GSK at its global sites and contribute to development of good practices.
While the majority of the responsibilities will be in the area of chemometrics and modeling, it is anticipated that a portion of the successful candidate's will be open for conducting technology development activities. Having suitable lab skills are preferred.
Authorization to work legally in the United States.

THE SPECIFIC DUTIES OF THE ROLE/POSITION:

The holders key accountability and responsibility will be to execute elements of the approved business plan that includes:
• Chemometrics aspects: To work as part of a multi-disciplinary development team to identify the most impactful model development and implementations that will derive unique process understanding when PAT solutions are being developed for biopharmaceutical processes in the lab, pilot and manufacturing settings.
• Process Modeling aspects: To work with the Biopharm-AMT subject matter experts and the wider Biopharm process development and manufacturing organizations to model processes to assess the impact of new technologies on cost-of-goods, efficiency and other performance metrics which will need to be developed. There will also be an element of comparing outputs from various modeling platforms.
• To provide leadership on PAT implementation projects for all aspect of multivariate analysis and associated modeling activities
• Lead implementation of models to support (new) technologies used for process and product development
• Work as part of a matrix project team to deliver team objectives based on priority and as much as possible in alignment with personal skills and experience
• To keep current with fast evolving pharmaceutical regulatory requirements using literature and networking / benchmarking.
• To translate process understanding and control strategy in a coherent manner to regulatory filings
• To advocate and support good data management principles for assigned late phase projects
• Provide support for technological transfer to Global Manufacturing focusing on modeling activities required to be in place throughout the product life cycle.

Contact information:

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