About us
Ardena is a leading Contract Development and Manufacturing Organization (CDMO) for the pharmaceutical industry. We help pharmaceutical companies, from small Biotech to large Pharma companies, bring their products to market through clinical trials. We offer a comprehensive and integrated portfolio of drug development services.
Ardena is a rapidly growing internationally oriented organization with a dedicated team of more than 750 professionals operating from 6 sites in Belgium, the Netherlands, Sweden, Spain and the United States. Ardena has an open and transparent culture : team spirit, an open mentality and ownership are important values in our company.
In recent years, Ardena has made a number of successful business acquisitions. These companies are complementary to each other and together form the One Ardena Group. We have achieved substantial growth every year for the past three years and our ambition is to continue this growth in the coming years. Do you want to work in a challenging contract development and manufacturing organization, where experts come together to create innovative medicines for unmet medical needs? Would you like to further develop Ardena by becoming our next colleague? Then we may have the perfect career move for you.
For the Ardena Nanomedicines Business Unit based in Oss, we are looking for a Senior Project Manager
WHAT YOU WILL WORK ON
As Senior Project Manager, you will take the lead in Ardena’s nanomedicines projects to ensure that goals and deliverables are met timely and within budget. Together with the Chemical Project Lead and Analytical Project Lead you will form the core project team, and act as Ardena’s point of contact for your customers.
With your expert knowledge, you guide our customers from preclinical development of their drug candidate to clinical GMP manufacturing. Based on the customer need and together with 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 until completion of all deliverables.
In your role as senior project manager, you mentor other junior project managers and contribute to the further implementation of required tools, the integration with other service lines and improvement of processes for our project management office.
YOUR KEY RESPONSIBILITIES
- You will translate customer demands and requests into proposals and work-orders and negotiate related timelines and budgets with the customer. You do this in collaboration with the core team members and representatives from Quality Assurance and / or Business Development.
- You will create realistic but progressive plannings for all stages of a project, including Process and Analytical Development, (non-)GMP manufacturing, batch release, stability studies and all related activities. You will work on, and drive forward, the delivery of that program in collaboration with the core project team, internal stakeholders, and the customer.
- You will provide regular updates on timelines, deliverables and budget. You will timely escalate potential issues, both internally and externally, and propose mitigation strategies when needed.
- Together with your fellow project managers, business development and line management, you keep track of the project pipeline and placement of new projects.
- You will engage in strategic discussions with customers and provide feedback and support with respect to CMC related questions.
- You are able to motivate team members and ensure alignment between all internal stakeholders (Process Development, Analytical Sciences, Production, Quality Assurance) and the customer to ensure realization of financial targets and customer satisfaction through delivery of projects to the agreed cost, timelines, scope and quality constraints.
- You take full accountability for your projects and contribute to solve problems in case these occur.
- You take a proactive role in implementation of required tools, the integration with other service lines and improvement of processes for our project management office and act as a mentor for junior project managers in the Business Unit.
- You will report to the Business Unit Director Nanomedicines.
YOUR PROFILE LOOKS LIKE / RESEMBLES
You have a BSc, MSc or PhD degree in for example (organic / analytical) chemistry, pharmacy or toxicology with at least 10 years of experience in the pharmaceutical industry. Experience with nanomedicine and drug delivery systems (DDS) is of added value.You have in-depth knowledge of and experience with development and commercialization of pharmaceutical products.You have extensive experience with cGMP and CMC in all stages of development from (pre)clinical to commercialization.You operate strategically within a commercial environment and have strong communicative skills.You are flexible, pragmatic, a problem solver and you connect people.You have an analytical mindset, are stress resistant, and show leadership.You are fluent in English (written as well as spoken), knowledge of Dutch is a plus.WHAT WE OFFER
A true learning environment where you will have the ability to grow your skillsA rapidly developing and growing international company with an attractive services, product and customer portfolioA dynamic working environment with nice colleaguesOpen, straightforward, but also caring cultureWe are true to our valuesAn attractive remuneration packageFlexible working hours30 days holiday a yearFruit & Fitness possibilities