We are searching for a suitable project manager to manage release and stability testing for Ebola vaccine.
For our client Janssen Biologics, one of the leading biotech companies with expertise in the manufacturing of vaccines & antibodies for infectious diseases. We are searching for a suitable candidate to manage release and stability testing for Ebola vaccine. In your role you will be accountable for the external laboratories at CRO's which will test our Ebola vaccine.
As such you combine your experience in quality control testing with your talent for keeping clear overviews. You need coordination skills to maintain the current processes and you should work together with other parties like External Manufacturing and Procurement to ensure all required assets are in place to enable efficient outsourcing and testing. You will work closely together with the COVID-19 test team (leveraging their network and expertise), the External Quality group & the Analytical development department (making sure all assays are transferred and qualified) as well as with the QA department of different manufacturing sites. You will be responsible to ensure timely testing of the products.
- Keeping clear overviews of different business processes;
- Seting up and maintain planning and reporting tools;
- Ensuring financial flows are managed;
- Ensuring standard processes with standard governance structures and Roles and responsibilities is set up and maintained with the external laboratories;
- Independently solve issues (including QI management) as well as solving issues with key stakeholders like Subject matter experts from Analytical development or manufacturing;
- Managing all systems, including data management to be utilized to ensure test results are accessible in time for release and stability;
- Ensure=ing timely and proper reporting to partners and stakeholders.
- Education: Bachelor grade and as a minimum;
- >3 years Experience in a pharmaceutical environment and good knowledge of GMP;
- Analytical knowledge;
- Experience with laboratory management systems;
- Demonstrable experience with project management and governance structures;
- Strong communication skills;
- Able to work independently;
- Flexible and accurate;
- Good organizational capabilities;
- Professional proficiency in English;
- Knowledge about the outsourcing process within a pharmaceutical company is advantageous;
- Valid EU work permit is a must
- Contract: temporary project through Oxford for 3-6 months;
- Salary: €4200- €5200 gross monthly based on education/ experience;
- Holidays: 25 (+12)
- Working hours: full-time, 32 hours discussable
- Remote possibilities: 80% remote 20% on site presence is required
- Region: Leiden
- Vacancy number: 17431
Oxford Global Resources is the largest recruitment agency within the fields of Science, Engineering and IT. All our recruiters have a relevant background within these fields and can help you find the perfect job through our extensive network.
As a specialist company we have a wide range of laboratory vacancies in Quality Control (QC) and Research & Development (R&D) within various sectors, including Pharmaceuticals, Biotechnology, Contract Manufacturing, Contract Research, Food Industry, Chemicals, Environment and Plants.
Oxford is always looking for talent with expertise in Biotechnology, Immunology, Biochemistry, Virology, Microbiology, Molecular Biology, Life Science, Analytical Chemistry, Physical Chemistry, Polymer Chemistry, Petrochemistry and Diagnostics. We are keen to meet candidates who have experience in one or more of the following techniques: USP (Upstream Processing) DSP (Downstream Processing), Bioprocesses, virus culture, cell culture, ELISA, FACS, Western Blot, SDS-page, PCR, RT-PCR, qPCR, cloning, sequencing, protein purification, purification, HPLC, UPLC, chromatography, physical chemistry, viscosity, melting point, pourpoint, pH, XRF, GC, GC-MS, LC, LC-MS, ICP ICP-MS, AAS, UV, titrations, Karl Fisher, formulation, sterility, determinations, bioburden, environmental monitoring, LIMS, GMP, GLP, GCP, GDP, ISO17025.
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