Fill/Finish 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 Healthcare organisation, based in Zuid-Holland Netherlands.

The Company

The company is dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.

Role Description

The main purpose of the Fill/Finish process development specialist is to set up the plans for process development, process characterization and process validation activities for the Drug Product manufacturing process. This needs to be done according to the project specific timelines and in compliance with applicable quality and regulatory standards. The related responsibilities 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 Janssen Vaccines & Prevention Leiden (JVL) and the (external) Drug Product manufacturing sites.

Responsibilities

- Accountable for the setup, reporting and timely execution of (outsourced) process development, characterization and validation activities;
- Responsible to ensuring close collaboration with the FFP manufacturing specialist and ensuring alignment with project needs through Technical Integrator;
- Responsible as technical subject matter expert in case product or process specific assessments are required;
- Responsible for timely informing/escalating issues as needed;
- Responsible to 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 applicable);
- In case studies are outsourced, responsible for review of the documentation prepared by the external partner that is required for process development, characterization and validation.

Requirements

- Education: MSc/BSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering;
- Specific Knowledge: In-depth understanding of Life Cycle Process Validation (including late stage process development, process characterization, process performance qualification and continued process verification) and GMP manufacturing of vaccines and/or large molecules;
- 8+ years of relevant experience;
- Deep understanding of vaccine and/or large molecule process development;
- Deep understanding of GMP drug product manufacturing processes;
- Proven track record of Life Cycle Process Validation;

Other information

Strong advantage:

- Lean 6 Sigma;
- Experience with technology transfers and outsourcing;
- English required (Dutch not needed);
- 32 hours discussible though fulltime is preferred;
- Must be able to travel up to 10% and stay abroad for up to 1 week.

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