Senior Technology Transfer Lead in Basel

veröffentlicht
Kontakt
Nikolina Babic, Randstad Inhouse Services Lonza Visp
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Basel, Basel-Stadt
Sektor
IT
Jobtyp
Temporär
Referenznummer
142523-1085
Kontakt
Nikolina Babic, Randstad Inhouse Services Lonza Visp
Telefon
+41 27 948 23 27

Stellenbeschreibung

For Lonza Drug Product Services (DPS), a successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland Randstad (Switzerland) AG has exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join Lonza by applying for the position as Senior Technology Transfer Lead. This position is temporary until end of the year 2021.

Key responsibilities:

Ensure all activities are performed according to current quality, regulatory and health and safety standards.

  • Manage technical activities for drug product transfers from clinical development to first commercial launch of assigned projects
  • Define and monitor project scope, timing and progress
  • Lead setup, scale-up and implementation of the technical drug product manufacturing processes at GMP DP manufacturing site(s) and provide technical on-site support
  • Responsible for process implementation and technical transfer documentation
  • Drive GMP change management strategy of assigned projects as well as initiate and manage GMP change control in system
  • Support preparation of regulatory documentation
  • Lead and support critical GMP product / process deviations and corresponding implementation of corrective/preventive actions (CAPAs)
  • Perform/support GMP and HA regulatory inspections and audits e.g. customer audits, PAI of assigned projects
  • Ensure all activities are performed according to current standards (Good Manufacturing Practice (cGMP), Health Safety Environment (HSE), Regulatory, etc.)
  • Enable innovation and technical strategy projects, generate IP and contribute to scientific publications and conference talks, and evaluate and implement of new methods and technologies

Qualifikation

  • Ph.D. or Master in pharmaceutical sciences, pharmaceutical engineering, chemistry, biochemistry, or related fields or similar qualification
  • Significant experience in biotech / pharma industry
  • Knowledge of technical issues and requirements for drug product technical transfers
  • Know-how in aseptic product manufacture for protein drug products including lyophilization process highly desirable
  • Excellent communication skills and command of English both written and oral
  • Good leadership and interpersonal skills; proven ability as team player and ability to manage cross-functional teams.
  • Very good planning and organizing skills, including project management and risk management skills