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. We strongly believe that our multidisciplinary approach can accelerate the drug development and approval process. By seamlessly integrating our services, we’re able to better mitigate development risks and ultimately reduce time-to clinic.
Ardena is a rapidly growing international orientated organization in the industry, with 7 company sites in 5 countries. (Belgium, the Netherlands, Latvia, Sweden and Spain). In recent years we have taken over several other organizations which are complementary to each other and created One Ardena Group. We currently have approximately 480 people working for us. We have realized an average growth of 15% on annual basis over the past 3 years and we have the ambition to continue this growth.
The Business Unit in Oss specializes in chemical process and analytical development, and cGMP manufacture of Active Pharmaceutical Ingredients (API) and nanomedicines. For the Ardena Business Unit based in Oss we are looking for a Project Manager API (FT)
What will you work on
You will take the lead in Ardena’s projects to ensure that goals and deliverables are met timely and within budget. Together with the PR&D Lead and Analytical Lead you will form the core project team, and act as Ardena’s point of contact for your customers.
Your key responsibilities
- You will translate customer demands and requests into proposals and work-orders, and negotiate related timelines and budgets with the customer in collaboration with the core team members and Business Development.
- You will create realistic but progressive plannings for all stages of a project, including Process and Analytical R&D, (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.
- Together with your fellow PM’s, business development and line management, you keep track of the project pipeline and placement of new projects.
- 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.
- You will engage in strategy discussions with customers and provide feedback and support with respect to CMC related questions.
- You take full accountability for your projects and contribute to solve operational problems in case these occur.
- You are able to motivate team members and ensure alignment between all internal stakeholders (Process R&D, Analytical Sciences, Production, Quality Assurance) and the customer.
- You will report to the (acting) Director of PM.
Your profile looks like/ resembles
- You have a PhD degree in (organic/analytical) chemistry, pharmacy or toxicology, combined with extensive experience in the pharmaceutical industry.
- You have in-depth knowledge of and experience with development and commercialization of pharmaceutical ingredients (like API’s) and/or pharmaceutical products.
- You have extensive experience with cGMP and CMC in the (pre)clinical development stages of development.
- You have strong organizational skills which allow you to oversee complex projects, and monitor progress of individual tasks.
- You operate strategically within a commercial environment and have strong communicative skills.
- You are flexible, pragmatic, a problem solver and a team player.
- 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 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
- 28 days holiday a year
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, professionals not entitled to work in the European Union will not be given a status update.
Agency calls will not be appreciated.