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Associate Director, PAT Analytical

CN-Wuxi

Responsibilities

Lead the effort to innovate and integrate process analytical technology (PAT) solutions to the continuous manufacture of drug products to generate data in the in-line and on-line mode.

Lead the development of new sensor development to continue expanding our in-line toolbox.

Analyzing samples using multiple techniques within the Molecular Spectroscopy functional area including NIR, FTIR, Raman and UV-Vis (off, on- or inline). 

Using statistical data analysis methods to evaluate analytical test data.

Develop effective digital and data science strategies and drive alignment across the network.

Active engagement with IT groups to integrate PAT sensor technology with IT/Data systems.

Connect, collaborate and partner with analysts, formulators and drug product manufacturing colleagues to progress our clinical program development and execution strategies.

Evaluate new technologies consistent with our online strategies.

Provide qualified technical guidance to junior R&D and Operations staff members.

Qualifications

Ph.D. in Analytical Chemistry or related discipline with at least 5 years, or M.S. with at least 8 years or B.S. with at least 10 years of industry experience.

Experienced spectroscopist with NIR, Raman, FTIR, UV spectroscopy with broad analytical chemistry hands on experience in the pharmaceutical industry.

Experience at developing, validating and transferring methods for application to continuous manufacturing and understanding of current regulatory environment are needed for this role.

Ability to communicate broadly & translate process requirements into process control and automation strategies.

Expertise in signal processing and is knowledgeable on controller validation, tuning and optimization.

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