Process Analytical Technology Specialist

Job description

  Job facts

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.

'Global Technical Development' (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, PTD actively collaborates and develops innovative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every day, continuously improving what it does.

“Small Molecules Technical Development” (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP) and analytical sciences, and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small Molecules (PTC) and PTD. PTDC is responsible for late stage technical development of our small molecules pipeline and the manufacturing of DS and DP for clinical studies across our small molecules manufacturing network.

Within Global Technical Development our Process Analytical Technology (PAT) section is responsible for the implementation of PAT tools to support drug substance and drug product development, scale-up and clinical supply. We develop spectroscopic analytical methods which provide additional information during laboratory process development and manufacturing. We make valuable contributions by enhancing process understanding, improving product quality and by supporting robust manufacturing processes and reliable scale-ups.

Good team working skills, a “can do” attitude, a strong customer focus and close collaboration with our internal partners (DS/DP development, clinical manufacturing, analytical development, quality and regulatory functions) is key to our success.

As PAT Specialist, you will develop pragmatic PAT solutions to support drug substance and drug product development and manufacturing. You will report to the Head of Process Analytical Technology. Main responsibilities are:

·  You will develop, optimize and validate Process Analytical methods
·  Hands-on setup of PAT tools in lab and production and running experiments in the team or independently
·  You will evaluate and implement new analytical technologies
·  You will participate in cross-functional teams
·  You will author and review technical reports, method validation and regulatory documents (e.g. IND/MDA submissions) & facilitate technology transfers to commercial manufacturing

As the ideal candidate, you will hold a PhD or MSc in Natural Science or Engineering and will have the following skills and qualifications:

·  Strong expertise in spectroscopy (e.g. NIR, Raman) and analytical techniques for on-line process monitoring, ideally with expertise in Real Time Release and/or Continuous Manufacturing
·  Strong chemometric skills
·  2+ years of industry experience (Pharma, Chemical, Biotech, Food, Petroleum,…)
·  High level of motivation and ability to commit to results and implement pragmatic solutions. Openness and flexibility to change as well as “out of the box thinking” ability
·  Excellent communication skills in German and English

Get in touch with the Recruiting Team Switzerland

Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Operational Excellence

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Roche is an equal opportunity employer.