Principal Scientist (Analytical Chemistry) (m/f/d)

Basel Stadt | Freie Mitarbeit 
|
Kategorie(n): Gesundheit
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Projektbeschreibung

Referenznummer: 478676/1
Startdatum: asap
Projektdauer: 12 MM++
Ort: Basel Stadt

Meine Aufgaben:
  • You will be responsible for the successful generation and use of analytical methods to control and monitor the performance of synthetic processes and the generation of GMP documents
  • Design, plan, perform, interpret and report results of analytical experiments for the preparation and timely delivery of chemical drug substances (DS, small molecules)
  • Manage all lab activities needed for the cGMP regulated release of raw materials and intermediates in the Chemical Development, supports/coaches team members and technicians, participates in technical project teams and contributes to overall strategies and goals of chemical development projects
  • Actively participate in scientific exchange groups within the company and external world as well as maintains excellent collaborations with the customers
  • Set the analytical, GMP and HSE standards for all aspects of development projects of her/his responsibility in alignment with the companies regulations and network decisions
  • Develop and validate methods together with a team of Analytical Lab Technician
  • Author, reviewer and/or approver of GMP relevant documents (e.g. analytical methods, SOPs, qualification reports for analytical instruments, etc...)
  • Write, check and/or approve analytical documentation and write/review reports (internal and reports to health authorities) and ensure adequate distribution of the information (e.g. in the project team)
  • Approve and release batch records and qualification documents according to SOPs
  • Fulfill all responsibilities according to GMP Responsibility List and the general responsibility list
  • Define the analytical strategy of development projects (proposes specifications, identifies by- and degradation products, re-test dates, storage conditions, and/or batch release decision according to analytical results, SOPs and the companies guidelines)
  • Co-author of regulatory CMC documents; provides answers to Health Authority requests in her/his field of expertise
  • With increasing Job grade: Take over the responsibility for the analytical strategy of more development projects of increasing complexity and importance
  • With increasing Job grade: Define the analytical strategy and has the oversight of all analytical aspects of an increasing number of development projects and acts as a supporter/mentor for less experienced colleagues
  • With increasing Job grade: Increasing analytical know how (Methods, SOPs, Development Manual, GMP requirements)
Meine Qualifikationen:
  • A motivated analytical expert (lab head analytical chemistry) with a focus on analytical separation sciences (e.g. HPLC or related hyphenation techniques)
  • Ideally you have a PhD in Analytical Chemistry. Experience as Post-Doc is also desirable
  • If you have a PhD or PD: Profound industry experience in a related field in pharmaceutical/chemical/life science industry
  • Professional experienence in Analytical lifecycle management (method development, method validation, transfer), Quality control, specification setting, CMC module preparation, basic project management skills preferably in a small molecule setting
  • Analytical techniques: Recognized achievements in the development of new analytical methods: main focus on Chromatographic separation techniques (LC-UV, LC-CAD, LC-MS, GC, GC-MS), as well as physico-chemical methods like Titrations (Karl-Fischer, Acid base)
  • Good knowledge of English (oral and written), good command of German (spoken/ written) would be a plus
  • Good knowledge of Software related: LIMS, eLN, Chromeleon, MS Office
  • Experience in a GMP setting is highly desirable
  • Profound literature search skills
  • Good presentation skills and scientific/technical writing skills
  • Good scientific leadership skills
Meine Vorteile:
  • You will work in an international environment
  • You will work in one of the biggest pharmaceutical companies of the world
  • Option for extension
Über Hays:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.


Einsatzort: Basel Stadt

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