PAT Senior Scientist, Process Attribute Sciences

Job Description

The Global Vaccines and Biologics Commercialization (GVBC) team within the Manufacturing Division focuses on late-stage process development, technology transfer, and in-line support of large molecules including vaccine and biologic therapeutic products. Our mission is to enable current and future compliant supply of our finest inventions to patients at a competitive cost through technical excellence. We serve manufacturing sites through the commercialization of our pipeline as well as by providing technical support to make, test, and release our products.

As a member of the Process Attribute Sciences team, you will integrate with a motivated and inclusive team of expert scientists passionate about the application of PAT tools to process development and routine manufacturing. The PAT Senior Scientist will be responsible for development, optimization, and implementation of new in-line, on-line and at-line analytical technology to support biologics and vaccine process understanding throughout the full product life cycle. The incumbent will have a strong technical background in spectroscopy (Raman, FTIR, NIR), multivariate (chemometrics) modelling skills and process control for large molecule drug substance and drug product processing. Your expertise will be applied to both traditional batch as well continuous manufacturing processes for diverse modalities in our large molecule pipeline and commercial product portfolio. 

You will have the opportunity to collaborate with GVBC groups as well as our Research Division partners to realize the implementation of process analytical platforms enabling highly capable manufacturing in our commercialization and in-line product manufacturing facilities. The incumbent will also be responsible for developing regulatory strategies to ensure the world-wide acceptance of innovative control strategies to be filed with our company's next generation process and analytical platforms. The scope of the contributions includes development and implementation of advanced real-time technologies to support development of new products as well as methods for process control applications in manufacturing to help meet the World Class Supply objectives of highest quality, lowest cost, and shortest lead time.

Job role expectations:

• Partner with scientists in upstream cell culture/fermentation, purification, and drug product operations areas to identify opportunities and optimize the use of process analytical technology methods to support process and product development in the commercialization lifecycle phase.

• Develop and validate in-line, on-line or at-line PAT methods to monitor and control process parameters or product quality attributes to support process understanding, product development studies, and comparability assessments.

• Apply chemometrics and multivariate data analysis techniques for PAT calibration and spectral data interpretation in alignment with process data.

• Lead the systematic assessment and deployment of PAT tools/testing and enable enhanced process control strategies.

• Support PAT scale-up and technology transfer to large scale manufacturing.

• Develop standard process analytics platforms encompassing all available tools to enable deep process understanding. These include, but are not limited to, biophysical/separations assays, in-line/on-line spectroscopic based methods (FTIR, Raman, NIR) and support other tools such as FBRM, on-line HPLC, in-line particle characterization, on-line MS.

• Develop integrated control strategies based on these analytical platforms that will enable highly capable manufacturing processes across a range of modalities (live virus and conjugate vaccines, mAb’ s, antibody-drug conjugates, and fusion proteins).

• Write technical protocols and reports ensuring compliance with applicable regulatory guidelines.

• Support scientific documentation, validation of PAT methods and contribute to regulatory filling sections regarding PAT methods.

• Interface with global regulatory agencies to ensure successful regulatory filings regarding PAT methods for process control and/or release.

Education Guideline:

• B.S./M.S. in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with 5+ years of relevant industry experience or a Ph.D. with 0+ years

Required Experience and Skills:

• Technical proficiency in the operation and troubleshooting of analytical instrumentation including vibrational spectroscopy (Raman, FTIR, NIR),

• Understanding of spectra interpretation, and analysis, with demonstrated capability in development of Process Analytic