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PROJECT MANAGER (H/F) (h/f)

Ref 1382222

Geactualiseerd op 23 februari 2021 via AQUILON PHARMACEUTICALS

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Aquilon Pharmaceuticals SA is a company that develops drugs for the treatment of pulmonary diseases through an innovative technology.
Focus Area:
Pharmaceutical development, including formulation and analytical aspects, i.e. Chemistry, Manufacturing and Control (CMC)Bioanalytical development and analysisLiaise with and participate in medical device (inhaler) development (drug-device combinations)
As Project Manager you will:
Undertake the full responsibilities for the development of products (planning, coordinating and supervising the activities of products developed by external centres and reporting their progress to the Management, other departments and partners), including all analytical developmentWork closely with key functions, especially within R&D department, to ensure that Aquilon's project teams have enough information to make appropriate decisions on program milestones and next stepsEnsure that R&D department meets the timelines and manage delays, negotiate delivery time and cater efficient information flow between internal and external teams - Negotiate and establish planning for Project budgets, and assess appropriate project scopesEnsure proper documentation of the pharmaceutical, (bio)analytical and medical device development to meet the corresponding regulatory and GMP/GLP requirementsEnsure Contract Development and Manufacturing Organization (CDMO) selection according to each product needsHave a global oversight of pharmaceutical activities, including the work of third parties, and ensure proper documentationHave a global oversight of the analytical and bioanalytical method development aspects to support pharmaceutical development, as well as nonclinical and clinical development

Profiel

Strong interpersonal skills with the ability to influence others in a positive and effective mannerDemonstrated ability to contribute to a continuous learning and process improvement environmentProven track record in product management or equivalent with knowledge of product management techniques and toolsDetail-oriented with the ability to proofread and check documents for accuracy and inconsistenciesAbility to understand and analyse scientific data and results, and review scientific documents including drug development reports, publications and regulatory submissionsStrategic thinking, strong problem-solving and analytical skillsUnderstanding the scientific principles and regulatory requirementsCommunication and motivation skills Strong sense of planning and prioritizationGood understanding of, and respect for, cultural differences, and capacity to work effectively in a multicultural environment
Knowledge of Inhalation and/or Bioanalytical would be a strong assetGood understanding of the product development process from formulation to registered batches manufacturing, and the regulatory requirements allowing successful registration with the authoritiesGiven that most of the new developments are targeted for the EU&USA, experience with EMA&FDA requirements is a must.

Talenkennis

Français : Bon
Anglais : Bon
Néérlandais : Elémentaire
  • Etudes, recherche et développement / Recherche fondamentale et appliquée

Hoe solliciteren?

Naam van de werkgever
AQUILON PHARMACEUTICALS
Contactpersoon
Mme Dieu Adeline
Presentatiewijze

envoyer une lettre de motivation et un C.V. via e-mail

Email
adieu@aquilonpharma.com
Opgelet! Het is niet nodig om Actiris te contacteren voor deze werkaanbieding. De vacature werd opgesteld door de werkgever. Actiris is niet verantwoordelijk voor de inhoud ervan en eventuele inbreuken tegen de wetgeving. Toch een opmerking over deze werkaanbieding? Aarzel dan niet om Actiris in te lichten.