Process Development Specialist

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.

The Company

The company is focusing their efforts and resources where the need is high. Their mission is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry think differently about diseases. Trying to achieve the best possible results for their health.

Improving the access to medicines, making the best available treatment at an affordable price, starting in this entrepreneurial company will kick-start/enrich your career!

Role Description

As a Fill/Finish process development specialist you will set up the plans for process development, process characterization and process validation activities for the Drug Product manufacturing process. This needs to be accomplished according project specific timelines and in compliance with applicable quality and regulatory standards. Related responsibilites focus mainly on late stage process development activities and process performance qualification until planning for Continued Process Verification as part of Life Cycle Process Validation.

In this position you will operate as the interface between the company and their (external) Drug Product manufacturing sites.

Responsibilities

- Accountable for the setup, reporting and timely execution of process development, characterization and validation activities
- Ensuring close collaboration with the Fill and Finish Process manufacturing specialist and ensuring alignment with project needs through Technical Integrator
- Being a technical subject matter expert in case product or process specific assessments are required
- Making sure that you inform/escalate issues timely as needed
- Provide input and review the required documentation which will be included in the filings
- Responsible for establishing and maintaining a trustful and professional relationship with the external partner
- If studies are outsourced you will be responsible for review of documentation prepared by the external partner that is required for process development, characterization and validation

Requirements

- Bachelor or Master of Science in a relevant discipline (pharmaceutical sciences/pharmacy/(bio)chemistry/Life Sciences/Engineering
- Minimum of 8 years' of working experience
- In-depth understanding of Life Cycle Process Validation, including late stage process development, process characterization, process performance qualification and continued process verification
- Experience in GMP drug product manufacturing of vaccines and/or large molecules

Other information

It will be a strong advantage if you have the following:
- Lean 6 Sigma
- Experience with technology transfers and outsourcing

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.