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  • Location

    Zuid-Holland , Netherlands

  • Job title:

    Process Development Specialist (Tech Transfer or Reg. Submission Writing)

  • Sector:

    Biotechnology

  • Job ref:

    45675

  • Start Date:

    2021-03-01

The Company 
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.

Role Description 
My client is looking for two different types of profile for this position:
1) Tech Transfer Specialist - responsible for product manufacturing tech. transfer;
2) Regulatory Submission Writing Specialist - responsible for providing technical content of the registration dossier


Responsibilities 

- Establish and maintain a trustful and professional relationship with the stakeholders from departments within the company as well as with external partners;
- Understand and provide input to define the technical content of the registration dossier, by guaranteeing availability of source documentation and data;
- Setup, report and timely execute process development, characterization and validation activities, which can be done in-house or externally
Lead and participate in specialized committees, to ensure continuous improvement on departmental and project level.

Requirements 

- BSc, MSc or PhD. in the life sciences
Proven experience in late-stage pharmaceutical development and GMP drug product manufacturing, including technology transfers
- Life cycle process validation; regulatory submission writing; technology transfer; process improvements.

???????Other information
Do you have any of those skills and you want to apply for this role? Please fill out your application via the apply button below and contact Guilherme Tokunaga at +31 (0) 20 658 98 01 or g.tokunaga@sire-search.com.
Contact Us

SIRE LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804