2 days ago

CMC Regulatory Operations Associate (Temporary position)

NovImmune S.A.

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Novimmune SA is a drug discovery and development company located in Plan-les-Ouates (Geneva) and Basel that focuses on developing antibody-based drugs for the treatment of inflammatory diseases, immune-related disorders, and cancer.  The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets.  The company has been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.


Novimmune is currently seeking a temporary CMC Regulatory Operations Associate, for an initial period of 6 months, within Biopharmaceutical Development and Supply in Geneva. The selected candidate will provide CMC regulatory operations support, expertise and knowledge to the Biopharmaceutical Development and Supply Department which is responsible for process development, process validation, non-GMP manufacture, management of external GMP manufacturing, regulatory oversight and supply of drug substance, drug product and finished product for clinical and marketed products.

CMC Regulatory Operations Associate (Temporary position)

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates (Geneva) and Basel that focuses on developing antibody-based drugs for the treatment of inflammatory diseases, immune-related disorders, and cancer.  The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets.  The company has been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.

Novimmune is currently seeking a temporary CMC Regulatory Operations Associate, for an initial period of 6 months, within Biopharmaceutical Development and Supply in Geneva. The selected candidate will provide CMC regulatory operations support, expertise and knowledge to the Biopharmaceutical Development and Supply Department which is responsible for process development, process validation, non-GMP manufacture, management of external GMP manufacturing, regulatory oversight and supply of drug substance, drug product and finished product for clinical and marketed products.

Key Responsibilities:

  • Support the provision of Quality modules for marketing authorisation applications (EU, US), clinical trial applications and for subsequent post approval and life-cycle management activities


  • Contribute to responses to Regulatory Agencies questions for marketing authorization and clinical trial applications regarding Quality modules and other modules as required


  • Provide support in preparation of  briefing  packages for Regulatory Agencies

     

      


Education / Qualifications:

  • Master in biotechnology or equivalent is required


  • At least 5 years of experience in CMC development activities for biologics are required


  • Knowledge of eCTD, particularly Module 3 is requiredKnowledge of regulatory requirements pertaining to the Chemistry, Manufacturing and Control of manufacture and development of biologics is required
  • Excellent project management skills, attention to detail and the ability to work cross-functionally
  • Effective verbal and written communication skills
  • Proficiency in the use of computers and business software applications
  • Good knowledge of GMPs and the know-how to work within a regulated environment in biological manufacturing
  • Good knowledge of oral and written English and French

If your profile matches the above description, please send us your CV and motivation letter in English under the reference Temp-ROA-2019 to the following email address:

hr-recruitment@novimmune.com

Chemin des Aulx 14 1228 Plan-les-Ouates