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 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 informationStrong 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.