Manager, Process Analytical Technology

  • Boston, MA

Employment Type

: Full-Time

Industry

: Miscellaneous



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Job Description: : Vertex is seeking a talented, experienced process analytical technology scientist. Working directly with our contract manufacturing organizations and our internal partners at Vertex, you will solve complex problems encountered in commercial production/manufacturing of drug products utilizing data analytics, spectroscopy, chemometrics, and wet chemistry analytical techniques. You will be part of an organization that thrives on innovation and is at the forefront of implementing Quality by Design, Continuous Manufacturing and PAT. To be considered for this position, the applicant will need to be a collaborative, experienced and competent spectroscopist and data scientist with a history of developing, implementing and troubleshooting spectroscopic methods and technologies in the pharmaceutical industry. A successful candidate will have the ability to influence colleagues and possess strong communication and negotiation skills. The scientist will need traditional lab experience to support research, investigations and continuous improvement, and must be able to creatively devise experiments to advance product and process understanding. In addition to chemometrics, the scientist must also have a strong background in statistical data analysis across pharmaceutical applications. Key Responsibilities: * Spectroscopic method development/validation/implementation/revalidation and model maintenance (in-house and working with CMO/CRO) * On-going support of commercial manufacturing activities utilizing continuous manufacturing processes and real-time release testing * Organization and analysis of PAT and continuous manufacturing process data for process insight, investigations and trending * Experimental design to support new product commercialization and root cause analysis for existing products * Execution of wet chemistry and PAT based experiments for continuous improvement and process and product understanding * Data collection, interpretation, trending and statistical process control * Method transfers to new CMOs and analytical support for second-source activities Qualification: Required Education and Experience * Ph.D. in relevant discipline and 2+ years of direct work experience, or * MS in relevant discipline and 5+ years of direct work experience, or * Experience in the pharmaceutical industry, proficient in an analytical development role * High emotional intelligence and strong negotiating skills * Strong communication and technical writing skills are required * Fluent and experienced in spectroscopic method development (NIR, Mid-IR, Raman, laser diffraction) * Experienced with chemometrics and multivariate modeling across spectroscopic techniques * Expert in a chemometrics software package such as Unscrambler, Matlab, PLS Toolbox, SIMCA, or native instrument software * Familiar with pharmaceutical manufacturing operations and online PAT measurements Preferred Qualifications: * Experience with GUI development for custom software solutions to data analysis and visualization, preferably in Matlab * Background in using analytical measurement systems to support development or to find root cause of manufacturing issues, including both PAT and wet chemistry techniques * Experience supporting commercial drug product analytical development activities * Experience in using on-line and at-line measurements to support QbD and on-going c continuous Improvement * Understanding of physical characterization method development (XRPD, laser diffraction, vision analysis, powder flow analysis, etc)


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