Keywords
- MSc. or PhD
- Manufacturing processes
- Technology transfer
- Upscaling
- Validation
Profile
Janssen Biologics B.V., a member of the Johnson & Johnson Family of Companies is looking for a Scientist Manufacturing Science and Technology (MSAT). As Scientist MSAT, you manage the process technology platform strategy for the production of biotherapeutics and vaccines in Leiden. As a teams, we are responsible for Validation and Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of all commercial production processes.
Responsibilities:
- Contribute to New Technology Introduction for the Site;
- Lead and/or support Life Cycle Management projects;
- Lead and/or support introduction of new technologies and digitalization projects;
- Act as Subject Matter Expert in USP and/or DSP for commercial manufacturing of pharmaceutical proteins and vaccines;
- Define (process) validation strategies;
- Write and review (process) validation protocols and reports;
- Responsible that validation studies are executed conform site standards and Johnson & Johnson guidelines and meet the quality requirements;
- Ensure integration of the global standards into local production processes;
- Act as primary interface between the Leiden site Operations, Quality, BTDS departments and the MSAT organization;
- Capable of leading and supporting complex investigations, facilitation of risk assessments;
- Act as SME during internal and external audits and inspections;
- Represent Leiden MSAT in global project teams.
Who we're looking for
The ideal candidate has a B.Sc. with at least 7 years of relevant experience or an M.Sc./Ph.D. with at least 4 years of relevant experience within pharma/biotech. You have project management experience and you are able to manage multiple moderate size projects. Additionally, you have experience with budget and resource planning, and experience with Trackwise.
Do you have experience with Technical Transfers, understanding of manufacturing processes from small scale to large scale, process validation and Process improvements, nd do you have excellent interpersonal skills? Then we are looking for you!
Department
The Manufacturing Science and Technology (MSAT) Team has the dedicated focus on
1. New Product Introduction (NPI) / Life Cycle Management (LCM);
2. (Process) Validation;
3. Process improvements;
4. Standards and new technology deployment.
Company profile
Janssen Biologics in Leiden, the Netherlands, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Vaccines. We combine our proven strengths with innovation to meet the needs of today and tomorrow. At Janssen Biologics, enthusiastic people are working together in a dynamic culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and commit to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past. Passionate about our mission? Join our team. Make your mark!
Additional vacancy information
Reference | : | A2400067 |
Contract | : | Temporary contract with CLS Services |
Education | : | WO/MSc.
PhD. |
Employment terms | : | Project for at least 1 year. Days of leave: 36 See here our other employment terms for this vacancy |
Publication date | : | 3-12-2024 |
Location | : | View location with Google Maps |
Contactperson | : | Claudia Erwich-Faaij |
| | +31 (0)88 22 77 555 |
CLS Services is a leading professional recruitment agency, specialised in the recruitment and secondment of people with a background in chemistry & life sciences.