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Director Formulation Development & Production

Director Formulation Development & Production

ArdenaGhent
30+ dagen geleden
Vacaturetype
  • Vast
Functieomschrijving

About us

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 over 700 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 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

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 LOOKS LIKE / RESEMBLES

  • Ph.D. in Pharmaceutical Sciences (Pharmaceutical Technology) or with equivalent through experience
  • At least 10 years of experience in the pharmaceutical industry in a GMP production or formulation environment
  • You have gained GMP knowledge in an industrial environment
  • You have proven skills to lead and motivate a team
  • Stress resistant and a make-it-work mentality
  • Excellent oral and written communication skills
  • Good command of the English language, being a native Dutch speaker is a plus

    • WHAT WE OFFER

    An attractive and tailor-made remuneration package including extra-legal benefits such as :

  • An attractive and progressive salary system including the following extra-legal benefits : company car, net expense allowance, mobile phone incl subscription, group insurance, hospitalization insurance, meal vouchers, eco vouchers and a group bonus system.
  • Compensation if you come to work by bike
  • Daily meal vouchers
  • Group + hospitalization insurance
  • Flexible working hours
  • 32 days holiday per year
  • Ability to grow your skills in a dynamic and rapidly growing company with an international customer portfolio