Biologics Drug Product Development Specialist 3364

26-8-2019 braine-l'alleud
company profile

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

job description

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

your contribution

- 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

what do we offer?

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.

summary
function
lab technician (m/f)
employment type
full time, freelance
contract type
immediate permanent employments
reference
CXRSP-84690
your Randstad contact
Aurélie Osée
aurelie.osee@cx.ausy.be 02 474 60 16
02 474 60 16