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

Réf 1382222

Actualisé le 23 février 2021 par 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

Profil

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.

Connaissances linguistiques

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

Comment postuler ?

Nom de l'employeur
AQUILON PHARMACEUTICALS
Personne de contact
Mme Dieu Adeline
Mode de présentation

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

Email
adieu@aquilonpharma.com
Attention! Il n'est pas nécessaire de contacter Actiris pour cette offre d'emploi. Le texte de l'offre d'emploi a été rédigé par l'employeur. Actiris n'est pas responsable de son contenu et des éventuelles infractions à la législation en vigueur. Si vous avez une remarque sur cette offre d'emploi, n'hésitez pas à la communiquer à Actiris.