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, 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.
We 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 us by becoming our next colleague? Then we might have the right opportunity for you.
For the Ardena Business Unit Drug Product Development and Manufacturing (DDM) based in Ghent (Belgium), we are looking for a
PROJECT MANAGER (CMC)
WHAT YOU WILL WORK ON
The Ardena Gent DDM Business unit located in Belgium provide clients with a full-service solution from formulation development, analytical method development and validation, demo batch production, stability studies, clinical GMP batch production, QC testing, labelling and randomization, QP release, storage and shipping through to regulatory support for molecules in the early phase of development. In 2022, our current drug product services in oral dosage forms (granules, capsules, tablets, solutions, etc.) will be expanded with aseptic fill and finish capabilities for the development and clinical production of small and large molecule injectable formulations.
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 (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
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 are true to our values
- 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 Stijn Maertens, email: HR@ardena.com, Tel: +32 9 267 65 00
Ready to apply? Please click on the application button
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 the European Union) will not be given a status update.
Agency calls will not be appreciated.