CMC Project Expert Manage CDMO partners

vor 3 Wochen

Baden AG, Schweiz gloor & lang ag life science careers Vollzeit

Our customer is a R&D driven biopharmaceutical company located in Zurich. Focused on Immune Response diseases. Our client develops exciting new MAbs and partners with big pharma in clinical development.
For further support with the growing CMC activities we seek to recruit an experienced CMC person. The position is defined on a temporary base and has high chance to develop into a perm role still this year.

Your role:

  • Manage assigned CMC activities for product candidates from pre-clinical through clinical development stages
  • Evaluate and manage external service providers (CDMOs, CLOs) for respective CMC deliverables
  • Monitor, analyze and report CMC project status to Director CMC and project teams
  • Compile and maintain CMC documentation in compliance with regulatory requirements by FDA, EMA, and Swissmedic

We are looking for an independent, experienced hands-on professional. On site presence in region Zurich is up to 4 days/week.

Your profile:

  • Life Sciences background (MSc in Biotechnology, Biochemistry, cell Biology or equivalent is required)
  • Experience in managing CMC activities with external contract manufacturing organizations
  • Familiar with GMP, manufacturing of and/or quality control of biotechnological or pharmaceutical products
  • Well organized, self-motivated and ability to work efficiently with a focus on deliverables.

Your autonomy, your integrity, and your initiative are of particular value. Your service-oriented approach will be of help to liaise with all internal and external stakeholders involved. Join our customer as the next reliable team member in this familial work environment. Working place is close to public transportation within Zurich area.

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