Junior Process Analytical Technology Expert Pharma Technical Development

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), analytical sciences and manufacturing S&T, 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, manufacture of DS and DP for clinical studies and Manufacturing Science and Technology (MSAT) across our small molecules manufacturing network.

Within “Small Molecules 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. Roche/Genentech PTD is currently implementing continuous drug substance and drug product manufacturing, where online-analytical methods play a vital role for process monitoring and control.

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 a PAT Expert, you will contribute to the development of the control strategy for continuous drug substance and drug product manufacuring processes by implementing state-of-the-art PAT solutions in R&D, clinical and commercial manufacturing. You will report to the Head of Process Analytical Technology.

Main responsibilities are:

·  You will develop, optimize and validate PAT methods incl chemometric models (with support from senior PAT experts)
·  Hands-on setup of PAT tools in lab and production environment and running experiments in the team or independently
·  You will evaluate and implement new analytical technologies
·  You will participate in cross-functional teams
·  Writing of technical reports and method validation

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

·  2 plus years expertise in spectroscopy (e.g. NIR, Raman) and analytical techniques for on-line process monitoring, or
·  2 plus years expertise with process or analytical development for continuous drug substance or drug product manufacturing
·  Experience with regulatory filings of PAT methods is of help
·  Expertise or background in Chemical and/or Pharmaceutical Engineering is of help
·  Chemometric skills and/or experience with multivariate data analysis
·  High level of motivation and ability to implement pragmatic solutions
·  Good team working skills and a “can do” attitude
·  Excellent communication skills in English and /or German (ideally both)

Roche is an equal opportunity employer.
Research & Development, Research & Development > Research

·  Who we are

At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.