Biologics Drug Product Development Specialist 3364

26-8-2019 braine-l'alleud
description de la société

Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.

description de la fonction

Do you have at least 10 years experience in biologics drug product development ?

Don't hesitate to contact me : aurelie.osee@cx.ausy.be

The Biologics Drug Product Development specialist will support the late stage project for the preparation of commercialisation:

- building of the drug product (DP) and packaging strategic development plan

- conducting yearly resource forecasting 

- support the building of the CAPEX & OPEX budget

- develop the 5 Years project plan 

- track all ongoing activities for the Biological Pharmaceuticals Sciences department 

- manage the team & resources as a matrix team

- coordinate meetings with the team - ensuring that all relevant project information is collated and shared

- accountable for CMC documentation

- communication of the strategy and status of plan

- timely escalation and deviations

vos atouts

- Minimum 10 years experience in biologics drug product development and steriles manufacturing within the biopharmaceutical industry

- An understanding of the issue and challenges of taking product from late stage development into comercialisation

- Good knowledge and technical experience in parenteral liquid drug product development and cGMP manufacturing under aseptic conditions would be required

- Good technical knowledge of sterile development covering drug product components, process transfer, scale and optimization

- Knowledge in primary and secondary packaging

- Good knowledge of cGMP and regulatory requirements

- Knowledge of analytical, preformulation and formulation development

- Understanding of biologicals drug product manufacturing process and scale-up

qu'offrons-nous?

We offer an attractive salary with extra-legal advantages :

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car
  • Monthly allowance (50 euros net per month)
  • A 13th month
  • Training
  • Etc

A rate as freelance is also possible.

sommaire
fonction
technicien de laboratoire (m/f)
type de job
temps plein, freelance
type contrat
jobs fixes immédiat
référence
CXRSP-84689
informations de contact
Aurélie Osée
aurelie.osee@cx.ausy.be 02 474 60 16
02 474 60 16