For this renowned Biotech I am looking for a Vaccine Technical Specialist acting as a key person for QC in complex issue handling and complex activity performance. The company is located in the south of The Netherlands, 1 day on site is ok.
*We can help with relocation for EU-citizens.
Main focus; lead the introduction of new methods and processes into the Quality Control department via the technology transfer process, represents the department in project teams, and manages the data of the applicable project
- Management of QC API test methods related to vaccine testing. Regularly assess manufacturing execution to ensure no process drift.
- Good understanding of QC testing and QC assay transfer of e.g HPLC assays, residual impurities (GC), endotoxin, compendial assays.
- Attends internal and external project core team meetings and regularly interacts with the client.
- Supports on time delivery on assay transfers and manufacturing process specific change controls, CAPA’s, Support Investigation Reports, Validation activities
- Visualize the progress of the project status/milestones and deliverables, flags concerns and risks in time to management and team, proposes mitigations and has a problem-solving oriented mind-set
- Drive and own improvement internal and cross-functional projects that support department KPI’s, with a focus on cost, innovation, on-time delivery and quality
- Manage projects from concept to completion; create and manage project plan, work cross functionally to ensure right first time and provide adequate training to impacted areas.
- Provides Quality Control representation to project team meetings. Responsible for relaying pertinent information such as production schedules and information requests to applicable Quality Control groups. Provides routine feedback regarding tech transfer and testing status.
- Writes, reviews, and/or approves method transfer related protocols/ reports and assessments.
- Assist in tech transfer activities related to Quality Control including generation of a Quality Control method transfer plan, method specific assay transfer protocols and reports, training plans, and project timelines
- Coordination of stability and providing protocol, additional sample request and reporting. Relays status updates in a timely and accurate manner.
- Master or BSc in biological, medical-technology or pharmaceutical sciences with preferably working experience in a GMP regulated environment.
- Strong know-how and Experience with cell- and micro-based assays is required, depending on the specialty (preferably +3 years of experience).
- Experience with vaccines
- General laboratory – and documentation experience is recommended.
- Strong GMP knowledge, knowledge about applicable guidelines and Quality awareness.
- Experience with technology transfer is preferred
- Strong communication skills in English
- Pref. September
If you’re interested in the above description, please apply with your CV by clicking on the ‘apply’ button. For further information, please contact Gemma Dozy at +31 (0)20 20 44 502 or by email at email@example.com