3 days ago

Senior pilot plant manager

Bracco Suisse SA

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Bracco Suisse SA is a company of the international Bracco Group (www.bracco.com), a leader in contrast agents for medical imaging. R&D is articulated between three Group’s centers in Colleretto Giacosa- Italy, next to Ivrea (CRB – Bracco Research Center), Geneva-Switzerland (Bracco Suisse S.A.) and Monroe-NJ, USA (Bracco Research US), which together form a know-how network of excellence.

The three centers – whose competencies are geared to continuous innovation– work on a coordinated basis.

For our research center based in Geneva (Switzerland) we are looking for a

 

Senior pilot plant manager

Bracco Suisse SA is a company of the international Bracco Group (www.bracco.com), a leader in contrast agents for medical imaging. R&D is articulated between three Group’s centers in Colleretto Giacosa- Italy, next to Ivrea (CRB – Bracco Research Center), Geneva-Switzerland (Bracco Suisse S.A.) and Monroe-NJ, USA (Bracco Research US), which together form a know-how network of excellence.

The three centers – whose competencies are geared to continuous innovation– work on a coordinated basis.

For our research center based in Geneva (Switzerland) we are looking for a

 

Activities:

Under the responsibility of the Pharmaceutical Technology department manager, you will have to perform the following tasks:

  • Manufacturing preclinical and clinical batches in clean rooms of the pharmaceutical pilot plant in accordance with Standard Operating Procedures, Good Manufacturing Practices
  • Writing, reviewing and/or approving R&D documents of pharmaceutical development relevance
  • Writing CMC documents to support submission to authorities (e.g. IND, IMPD)
  • Responsible for technology transfers from Research laboratory to pilot plant and from pilot plant to industrial scale
  • Contributing to the GMP quality system in place within Bracco
  • Key person for Swissmedic SMF and for Health Competent Authorities during inspection
  • Managing Development projects in close collaboration with various functions from the R&D and group entities
  • Managing a team of technicians of the Pilot Plant, and as such, be a force for bringing forward proposals and support continuous development of laboratory technical capabilities and career development of the technical team

Qualifications:

  • Pharmacist or Chemical engineer, you have at least 10 years of professional experience in pharmaceutical development activities
  • Expertise in lyophilization process
  • Formulation of parenteral Drug Products, including aseptic processed and terminal sterilized ones
  • Good knowledge of aseptic filling in a GMP environment and previous experience in scale-up of processes
  • Experience of working in a R&D environment, with inherent flexibility and open-minded attitude
  • Good knowledge of drug development processes and of all regulatory aspects relating to clinical trials
  • Quality Assurance and GMP expertise particularly with respect to Annex 1
  • Proven experience of team leading/management
  • Proven experience of project leading/management in an international and multicultural environment;
  • Basics knowledge of biology, biotechnology and medical imaging
  • Proficient written and spoken command of French and English

We offer:

  • An international company working on medicinal products with high added value.
  • An extremely stimulating field of research within a scientific environment highly specialized and qualified.
  • A work environment with state-of-the-art technologies
  • A challenging job with means to succeed and possibilities for continuing education and growth

 If you recognize yourself in this profile and are looking for a new challenge, send us your complete application (CV & letter) only by email, through the JOBUP website.

 

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