Project Manager Ebola
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a Project Manager Ebola.
We are searching for a suitable candidate to manage the release and stability testing for the Janssen Ebola vaccine. In your role you will be accountable for the external laboratories (QC testing and NCL) which will test the Ebola vaccine.
You will 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 of the vaccine. You will work closely together with the COVID-19 test team (leveraging their network and expertise), the COVID-19 NCL team, the External Quality group (keeping oversight on the ECL´s), 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.
Your Main Tasks and Responsibilities will be:
- Keep clear overviews of different business processes;
- Set up and maintain planning and reporting tools;
- Ensure financial flows are managed;
- Ensure a standard process 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;
- Manage all systems, including data management to be utilized to ensure test results are accessible in time for release and stability;
- Ensure timely and proper reporting to partners and stakeholders.
Who we're looking for
The ideal candidate has a least a BSc. degree and 3 -5 years of relevant pharmaceutical experience in a GMP environment. You have experience in a pharma Quality Control or Analytical Development laboratory and experience with project management and governance structures.
Other preferred requirements for the job:
- Experience with laboratory management systems;
- Experience in a Quality Assurance or Compliance related function;
- Experience with NCL testing;
- Lead auditor qualification;
- eLIMS experience;
- Knowledge about the outsourcing process within a pharmaceutical company.
As a person you have good communication skills in English (Dutch is a nice to have) while you are in close contact with production sides and contract labs. You have excellent organisational skills and can keep good overview.
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||80% remote, 20% onsite in Leiden.|
Salary: > 52000
Days of leave: 25 + 11
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.