Associate Global Project Manager in Basel

veröffentlicht
Kontakt
Dominik Udovicic, Zürich Professionals IT
Jobtyp
contract
Jetzt bewerben

job details

veröffentlicht
Ort
Basel, Basel-Stadt
Sektor
IT
Jobtyp
contract
Referenznummer
9859
Kontakt
Dominik Udovicic, Zürich Professionals IT
Telefon
058 201 56 60
Jetzt bewerben

Stellenbeschreibung

Associate Global Project Manager

Currently we are looking for Associate Global Project Manager in Global Biologics Manufacturing Science and Technology Drug Product Europe, beeing responsible for:

  • providing technical expertise for commercial aseptic drug product manufacturing at contract (CMOs)
  • ensuring technical leadership for commercial process transfers to CMOs
  • defining and guide commercial drug product production network alignment activities.
  • providing technical support to the Technical Product Management organization.

Tasks

Lead or participate in cross-functional and/or cross-site technical projects and teams to provide technical expertise to commercial aseptic drug product manufacturing activities at CMOs and/or process transfers to CMOs. This includes:

  • technical inputs into the CMO strategy
  • technical feasibility and expertise for process decisions
  • technical aspects for health authority interactions
  • definition of process validation strategy
  • technical leadership of risk management activities

additionally:

  • Serve as a point of contact as a core member of the CMO Joint Management Team.
  • Write and/or review regulatory submissions and reports.
  • Identify, develop and communicate manufacturing best practices and harmonized business processes.
  • Participate in cross-site and cross-functional teams.
  • Support the Technical Product Management organization in serving as a member on the product teams.
  • Collaborate closely with the CMO site management, quality site management, etc.

 

Education, Experience, Knowledge and Skills

  • Advanced degree in life sciences or engineering
  • 5 - 7 years of professional experience in pharmaceutical industry, including 3 years in aseptic drug
  • product formulation, process development or manufacturing
  • Technical experience in aseptic manufacturing of commercial biological drug products
  • Skills as a project leader
  • Effective communicator; solid written, oral and interpersonal communications and presentation skills
  • Ability to collaborate and negotiate solutions in fast paced matrix environment interacting at various functional levels
  • Strong quality orientation with good knowledge of cGMPs, regulatory guidelines and validation practices
  • Strong analytical and creative problem solving skills to address a broad range of complex problems
  • Ability to make sound decisions by considering degree of impact on individual business units
  • Flexibility in work hours and travel (approx. 20%) to meet business objectives

Further Qualification:

  • Very good spoken and written command of English and German.
  • Skilled with standard office apps and biopharmaceutical industry systems.