(Sr. Associate) Scientist MSAT

NPI, LCM, Improvements, Validation

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for a (Sr. Associate) Scientist MSAT.

Keywords
  • Biotech/Pharama
  • New Product Introduction (NPI)
  • Life Cycle Management (LCM)
  • Process Improvements
  • Validation

As (Sr. Associate) Scientist, you are a member of the Manufacturing Science and Technology (MSAT) Team with the dedicated focus on:
  • New Product Introduction (NPI) / Life Cycle Management (LCM);
  • (Process) Validation;
  • Process improvements;
  • Standards and new technology deployment.
You responsibilities are:
  • Contribute to LCM/New Technology Introduction for the site;
  • Lead and/or support Life Cycle Management projects;
  • Lead and/or support introduction of new technologies and digitalisation 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;
  • Make sure validation studies are executed conform site standards and Johnson & Johnson guidelines and meet 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 organisation;
  • 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.

Profile

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 New Product Introduction (NPI) / Life Cycle Management (LCM), (Process) Validation and Process improvements, and do you have excellent interpersonal skills? Then we are looking for you!

Benefits

Project for at least 1 year, extension anticipated.
32-40 hours, 2 days/week on site.

Company profile

Janssen Biologics in Leiden, the Netherlands, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Vaccines. They combine their 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. They are proud of their Credo values and their diverse environment and commit to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way they support their patients. Together, they strive for a future in which disease is a thing of the past. Passionate about their mission? Join their team. Make your mark!

Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A2400010)
Location Leiden
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(Sr. Associate) Scientist MSAT

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