Project Description

Job Description

Our client is an innovative biotech company with a strong expertise in the development of stem-cell regenerative medicines.

He is looking for his Manufacturing Sciences & Technology (MSaT) Director – non-clinical stages (m/f).

His/her main responsibility will be:

  • To provide scientific, non-clinical (in vitro and in vivo) and CMC advice and ensure the execution of the process development, product characterization and non-clinical strategy.
  • To lead and provide strategic direction for the Product development and ensure full compliance of quality.
  • To be an insightful leader with abilities to develop and mentor people and implement strategic and tactical plans to drive development plans.
  • To lead the MSaT Team (6 persons) and manage department budgets.

The MSaT Director will report to the Chief Technology Officer.

An open-ended employment contract is proposed together with an attractive compensation package (including company car) and exciting career perspectives.

Postulez :

    J’autorise ce site à conserver mes données transmises via ce formulaire. Les données sont récoltées à l'exclusivité pour Expert Select. Aucune exploitation commerciale ne sera faite des données conservées.     Plus d'informations sur la page Politique de gestion des données personnelles.

    Main Responsibilities

    • You design CMC, product characterization and non-clinical safety plans that support clinical trials and marketing applications.
    • You lead pharmacology and safety studies of potential new medicines.
    • You maintain effective interactions with the basic research, clinical operations, pharmaceutical operations, and regulatory affairs teams.
    • You are a key player in writing regulatory documents including non-clinical sections such as IND’s, IMPD’s, CTA’s and BLA’s.
    • You initiate the development of performance metrics on projects and studies
    • You contract, monitor, review and sign-off on GMP, non-GLP and GLP studies conducted by various CRO’s.
    • You follow up research at CRO’s and take decisive actions.
    • You achieve financial objectives by preparing budgets, scheduling expenditures, analyzing variances, and initiating corrective actions.
    • You regularly report projects evolution to the top management.

    Profile

    • PhD in immunology, biology, biochemistry, pharmacology or medicine.
    • Min. 5 years industry experience in pharmaceutical or biotech companies.
    • Experience with biologics. Experience in ATMPs, and/or orphan-indication products development is an asset.
    • Track-record of successfully managing non-clinical projects (safety, toxicology, pharmacology…)
    • Track record of providing strategic oversight for preclinical and clinical study protocols, reports, and publications.
    • Good knowledge of CMC development strategy (process development and validation; product characterization)
    • Good knowledge of GMP, GLP and regulatory requirements (FDA, EMA, ICH).
    • Strong organizational and interpersonal skills, with attention to details.
    • Excellent written and verbal communication skills, and assertivity.

    Associé en charge

    Retour à la liste de jobs