Role DescriptionThe 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 at the technical 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 Fresh Frozen Plasma 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- MSc/BSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering. - 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; - Experience: 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; - Experience with technology transfers and outsourcing is a strong plus.
Other informationYou start with a 1 year contract, followed by extension or a permanent contract.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.