Director Formulation Development and Production

As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, Ardena is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated portfolio covering drug substance and drug product development, manufacturing, logistics, and bioanalytical services.

With a rapidly growing international orientation, Ardena boasts a team of 500+ professionals operating across five strategically located sites. Our presence spans Belgium (Gent), The Netherlands (Oss and Assen), Spain (Pamplona), and Sweden (Södertälje). Embracing an open and transparent culture, we hold team spirit, an open mindset, and ownership as key values within our organization.

We are a dynamic force in drug development, offering compelling career opportunities to skilled and motivated individuals seeking to make their mark in the rapidly expanding global pharmaceutical industry. If you're looking to thrive in a challenging contract research and development environment, collaborating with experts to innovate drugs for unmet medical needs, Ardena could be the ideal workplace for you.

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

DIRECTOR FORMULATION DEVELOPMENT AND PRODUCTION

YOUR KEY ROLE

Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.

The main role of the Director Formulation Development and Production is to manage and lead a team of highly skilled R&D and GMP scientists. You are expected to set the overall strategy and structure for your department, ensuring the available technologies, approaches and team are in line with the market expectations and the Ardena growth targets. You are responsible for the planning and execution of R&D and GMP projects (sterile and non-sterile), taking decisions on scientific challenges, managing HR-related questions, promoting business development by supporting Technical Sales and assuring proper interactions with other departments.

YOUR KEY RESPONSIBILITIES

• Responsible for short- and long-term planning of all Formulation, non-sterile GMP Manufacturing and sterile Fill & Finish GMP Manufacturing activities

• Mentoring the Team Leaders and Formulation Scientists to increase the quality of their work (acting as a scientific support in R&D projects)

• Giving scientific input during client meetings for Formulation Development work and supporting the Formulation Scientist during scientific discussions

• Problem solving, both for R&D and GMP Production, from technical issues
  (e.g. equipment) to scientific challenges (e.g. formulation/process development) and quality/GMP related issues

• Keep up to date with drug delivery and formulation technologies

• Evaluate and implement new technologies, equipment and excipients

• Supporting in Technical Sales (Business Development), guiding the client towards the most suitable formulation strategy

• Review and approve Formulation Development reports, Technical Batch reports and GMP Manufacturing reports

• Providing input on and reviewing Statements of Work (work offers)

• Facilitating Tech Transfer from ‘R&D mode’ to ‘GMP level’

• Responsible for the people management of a team of around 15 scientists including recruitment and training of new team members

• Being a formal member of the DDM-BE Management Team (MT): actively participate in strategic discussions concerning the growth of the business

• You will report to the Business Unit Director DDM-BE

YOUR PROFILE

• Ph.D. in Pharmaceutical Sciences (Pharmaceutical Technology) or equivalent through experience

• At least 10 years of experience in the pharmaceutical industry in a GMP production or formulation environment. Additionally, you have at least 2 years relevant managerial and leadership experience

• You have gained GMP knowledge in an industrial environment
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