Principal / Senior Principal Scientist in Pharmaceutical R&D

 
Published
WorkplaceBasel, North West Switzerland, Switzerland
Category
Position
Roche Search Global Web Site : Careers Roche Language: DE

Switzerland, Basel-City, Basel

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  • Job facts


  • Principal Scientist / Senior Principal Scientist in Pharmaceutical Research and Development

    This position is part of the Pharmaceutical Research and Development organization. Within Pharmaceutical Research and Development, we transform molecules to medicines by designing and delivering customized clinical formulations and developing robust commercial drug products that benefit patients. 

    As a (Senior)- Principal Scientist in Drug Product Development, you are responsible for developing robust formulations and lean manufacturing processes for oral dosage forms of new chemical entities. Furthermore, you are driving scientific initiatives,  and supporting the department in defining the scientific strategy to assure the scientific excellence in Pharmaceutical R&D. In this position, you work closely in international teams together with scientists and management from other disciplines (chemistry, analytics, quality, regulatory and commercial production) and you represent the department in technical development teams (CMC) and scientific boards.

    The main responsibilities of this challenging position include:

  • Development and optimization of robust formulations and manufacturing processes for oral solid drug products using various manufacturing technologies (i.e. batch and continuous mode) including the scale-up and transfers to commercial manufacturing sites to facilitate the successful process validation at the sites. 

  • Routine usage of statistical tools (e.g. DoEs), risk assessment tools for QbD (e.g. QRA, FMEA) and Modelling and Simulation tools.

  • Expanding the scientific excellence within Pharmaceutical R&D by the implementation of new and innovative manufacturing technologies. Review of scientific literature to extract relevant trends and integrate innovative concepts and technologies in the scientific strategy of the department. 

  • Inspiring and actively influencing scientific teams at Roche as well as external e.g. international scientific consortia

  • Authorship and review of technical reports, manufacturing instructions, process validation documents, and the CMC parts of regulatory submissions to support licensing.  Preparation of technical documentation (e.g. development reports) to support CMC regulatory submissions.

  • Contributing actively to the intellectual property values protection  of our Roche products



  • Requirements:

  • PhD in Pharmaceutical Technology / Master in Pharmaceutical Technology,  chemical/process engineering or material science background plus more than 8 years industrial experience in drug product development of oral dosage forms preferred

  • Broad experience in the development, optimization, scale-up and transfer to the launch site of standard manufacturing technologies for oral dosage forms including the authoring of CMC sections of regulatory dossiers and interaction with health authorities.

  • Experience in developing complex drug delivery technologies, as well as special technologies for pediatric and geriatric patient populations, in close collaboration with external  CMO/CLO’s.

  • Understanding of digital transformation and tools such as (advanced) data analytics, data science, predictive modeling & simulation, etc and their impact on business process and end-user experience is preferred.

  • Highly motivated and able to work collaboratively as well as independently and proven record to drive for results and implement innovative solutions.

  • Openness and flexibility to change as well as "out of the box thinking" skills

  • Willingness to travel occasionally

  • Has a strong network within the pharmaceutical community with expert peers

  • Excellent communication and fair teamplayer skills



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    In your application, please refer to myScience.ch and reference JobID 53422.


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