Challenging coordinating position at our client Janssen Biologics Manufacturing in Leiden. In this role you will play an active role in vaccine process validation for commercialization.
Analyst Stability, NPI &New Technology team One Lab
As a part of the ONE JSC Lab situated at the Janssen Biologics Manufacturing site in Leiden, Stability, NPI & New technology group is responsible for the oversight of stability and release programs of commercial biological products such as Darzalex, Remicade, Stelara and products in process validation for commercialization such as CNTO4424, GPRC5D, CD3 etc.
The services provided by this department also include technical transfer of the NPI’s, data management, release testing of raw materials, biological drug substances and drug products.
For our team, we are looking for an analyst that will be responsible for the release and stability coordination and single point of contact for commercial product coordination within Leiden QC.
Responsibilities
- The Analyst coordinates the release of raw materials, drug substance and drug products from internal and external stakeholders (CMOs) to ensure on-time delivery of results per agreed timelines.
- The Analyst coordinates the stability testing of JSC large molecule products according local procedures and agreed timelines.
- The Analyst is a subject matter expert on release and stability processes and has a leading role during the GMP inspections.
- The Analyst joins meetings of the quality network organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM) to ensure flawless experience
- The Analyst is responsible to coordinate all Data requests provided by various stakeholders (RA; Health Authority; DPDS etc) and has the accountability to plan, organize, prioritize and execute the Data Requests based on the stakeholder requests.
- The Analyst has affinity and motivation to lean the process continuously and to apply Business Excellence and Faster Forward tools.
Profile
- Education minimum relevant HBO diploma
- At least 3 years of work experience in the pharmaceutical environment
- Must have 1-2 years of Project Management experience
- Excellent interpersonal and organizational skills
- Excellent communication skills (oral and written English)
- A quality, compliance and business minded attitude and flexibility
- Knowledge and Affinity with Business Excellence tools and Faster Forward mindset
- Flexible and agile, capable of handling multiple requests and changing priorities
- Proficient in the use of lab systems & lab environment, particularly around data integrity and data management (eg. eLIMS)
Terms of employment
- Employment: temporary contract with prospect of a permanent contract
- Salary indication: from € 2700 to € 3900
- Working hours: 40 hours per week (part-time 32h can be discussed)
- Location: Leiden region