Your new company

Our client is a leading company in global biopharmaceuticals with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. With 69,000 employees operating in more than 140 countries, our client offers state-of-the-art laboratories, plants and offices that are designed to inspire their employees as we learn, develop and grow.

In Oss, there are two large production sites that are formerly known as Organon. The first location, Biotech Operations, produces novel biologic active ingredients (“drug substance”). Their activities are split between USP (cell culturing/microbiology in bioreactors up to 22,000 litres) and DSP (filtration and purification of product). The other location, Pharmaceutical Operations, focuses on the production, packaging and distribution of various end products (tablets and injectables) and birth control products.

Your new role

As Process Improvement Specialist, your main focus will be defining and driving product and process improvements for the manufacturing of drug substances. This will be done by executing the continuous process validation plan for the defined products, and defining product related improvements, based on the data obtained. You will also provide high-level investigational support to the IPT and collaborate with relevant site functions on investigation or improvement projects when necessary. Other responsibilities include but are not limited to:

• Review and approve Master Manufacturing Records in accordance with procedures and GMP compliance.

• Support authoring and review of regulatory files to support new product introduction or changes to regulatory files.

• Change owner for complex, multi-departmental or multisite changes. Provides process chemistry impact assessments, and technical assessments on IPT initiated changes.

• Write and review continuous process validation reports in close collaboration with IPT, including trend data using statistical tools and templates. Supports IPT in CAPA trend analysis to evaluate if process chemistry related challenges are being mitigated.

• Responsible for second line process troubleshooting for both clinical and commercial products.
  
  

What you'll need to succeed

The successful candidate will have completed at least a Master’s Degree in either Life Sciences, Biotechnology, Engineering or another technical field. PhD or PDeng/EngD are also welcome to apply.

• A minimum of 5 years of relevant experience in biologics or vaccine manufacturing and/or managing biotechnological development projects, gaining experience with project management. A minimum of 2 years of relevant experience if a PhD degree is applicable.

• Hands-on experience with change management and Lean Six Sigma tools and a high standard for compliance and GMP.

• Broad interest in the biotechnology field is preferred, and eagerness to learn is a must.

• Must demonstrate personal commitment with respect to working safely, healthily and environmentally friendly with adherence to GMP regulations.

• Excellent English communication skills, both oral and written, are essential. Dutch is highly preferred.
  
  

What you'll get in return

Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is anticipated. In this position, you will get a competitive salary and your travel expenses are covered.

What you need to do now

If you are interested in this role as Process Improvement Specialist, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion about your career.