Project Manager (CMC)

  • Ghent, BE
  • 3 months ago

Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development services.

Ardena is a rapidly growing international orientated organization in the industry, with 6 company sites in 4 countries (Belgium, the Netherlands, Latvia and Sweden). Each Business Unit has its specialization. The organizations specialties are complementary to each other and created One Ardena Group. We currently have over 320 people working for us and have realized an average growth of 15% on annual basis over the past 3 years. We are ambitious! For you the possibility to expand and transfer your knowledge, grow and develop with us.

For the Ardena Business Unit Drug Product Development and Manufacturing (DDM) based in Mariakerke (Gent, Belgium), we are looking for a

PROJECT MANAGER (CMC)

What will you work on

As project manager in the drug product development and manufacturing team, you are the primary point of contact for our customers. You guide our customers from (pre)clinical development of their drug product and associated analytical methods to clinical GMP manufacturing.

Based on the customer need and together with the DDM technical experts, you define the project scope and design. You manage the project on a daily basis, from negotiation with the customer on project design and budget, through high level follow up on the execution of the project plan within Ardena Gent DDM, until completion of all deliverables. You make the connection between the customer and the internal DDM organization to assure project deliverables in accordance to set timelines, budget and agreements.

Your key responsibilities

  • 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)

Your profile looks like/resembles

  • You have a master or PhD degree in a scientific discipline (Pharmacy, 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

What we offer

  • 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 love creative thinking and pro-activeness
  • We are true to our values

Next to that we also offer of course

  • An attractive remuneration package
  • Flexible working hours
  • 32 days holiday a year

If you like to have more information about the role, please do not hesitate to contact Lieven Van Vooren, email: Lieven.VanVooren@ardena.com

Ready to apply?  send us your cv and motivation letter via our website ardena.com/careers or email at HR@ardena.com

Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals not entitled to work in Belgium will not be given a status update.

Agency calls will not be appreciated.