As 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 done according to the project specific timelines and in compliance with ...
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Vaccines & Prevention, we are searching for a Fill/Finish Process Development Specialist.
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.
As 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 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 at the technical interface between Janssen Vaccines & Prevention Leiden (JVL) and the (external) Drug Product manufacturing sites.
- 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;-
- In case studies are outsourced you are responsible for review of the documentation prepared by the external partner that is required for process development, characterization and validation.
Who we're looking for
We are looking for a candidate with a MSc or BSc in a relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering. You have at least 10 years of experience in vaccine and/or large molecule process development and GMP drug product manufacturing. Experience with Life Cycle Process Validation for Drug Product manufacturing and/ or experience with technology transfers and outsourcing is a strong advantage.
Are you the enthousiastic teamplayer we are looking for?
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Full time preferred, 32 hours discussable. Longer-term anticipated. Must be able to travel up to 10% and stay abroad for up to 1 week.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555
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