Project Manager CMC.

Ardena is a leading contract development organization for the pharmaceutical industry. They assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. They provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.
Ardena is a rapidly growing international orientated organization with a dedicated team of about 500 professionals operating from 7 sites in Belgium (Gent), The Netherlands (Amsterdam, Oss, Assen), Spain (Pamplona), Sweden (Sodertalje), and Latvia (Riga). Ardena has an open and transparent culture: team-spirit, an open mindset and ownership are important values in our company.
They are a dynamic drug developer offering exciting career opportunities to skilled and motivated people who want to work in a fast-growing market within the global pharmaceutical industry. Do you want to work in a challenging contract research and development environment, where experts come together to develop innovative drugs for unmet medical needs? Do you want to further develop Ardena and grow with them by becoming their next colleague? Then we might have the right opportunity for you!

Locatie
België.
Bedrijf
Ardena
Publicatiedatum
2021-10-27 10:15:42

Job omschrijving.

  • Define project scope based on customer needs
  • Developing project design (content, overall plan, budget, timelines) together with Ardena Gent DDM technical experts
  • Draft Statement of Work and follow-up approval process
  • Planning, management, coordination, and financial control of approved projects
  • Leading the core project team (including DDM galenic lead, analytical lead and QP) and clearly communicating the agreed strategy and deliverables to all stakeholders
  • Draft and follow up on the Technical Quality Agreement and the Quality Agreement
  • Review and approval of scientific protocols and reports
  • Conflict resolving; at all times facilitating decision making in order to drive the project forward
  • Communicating progress of the project to customer as first point of contact
  • Maintaining relationship with existing customers and pro-actively advise customers on next steps/projects for their current and future projects
  • You keep yourself up to date with the latest developments and insights
  • You will report to the scientific director (director of project management office)
  • You will closely work together with our customers and all DDM departments (Formulation & Production, Analytical Development, Quality, Facility & Material Logistics)

Profiel van de kandidaat.

  • You have a master or PhD degree in a scientific discipline (Pharmaceutical Sciences, Biotechnology, Bioengineering, Biomedical Sciences or similar)
  • You have at least 1 to 3 years of experience in CMC
  • Hands-on experience in drug product analytical and/or formulation development and/or GMP is a strong added value
  • You have excellent planning and organizational skills with demonstrated ability to deliver work on-time
  • You are customer-oriented
  • You are flexible, a problem solver and a team player
  • You have an analytical mindset and you are stress resistant
  • You have good communication skills and are fluent in English (written as well as spoken)
  • You feel comfortable in a dynamic and changing environment
  • You like to learn and develop yourself

Werkomstandigheden.

  • A true learning environment where you will have the ability to grow your skills
  • A rapidly International developing and growing company with an interesting services, product and customer portfolio
  • A dynamic working environment with nice colleagues
  • Open straightforward but also caring culture
  • We are true to our values
  • An attractive remuneration package
  • Flexible working hours
  • 32 days holiday a year

Contact.

If you are interested in this position and would like to know more about it, please contact:

Nele Geusens, PhD, Recruitment Consultant
T: +32 497 57 08 94
E: geusens@themagroup.eu

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