Cmc Expert Analytical Development Focus Parenterals&devices

Roche

Basel, Switzerland
Not specified (assumed hybrid/onsite based on company culture)
Expert analytical development of parenterals
Nda preparation and regulatory submission
Root cause analysis for complex cmc issues
Roche is seeking a CMC Expert with a focus on analytical development for parenterals and devices, located in Basel, Switzerland. The role emphasizes providing scientific guidance, leading complex CMC issue resolution, and mentoring within Roche's collaborative and inclusive culture

Job Summary

  • The role involves providing expert scientific guidance to project teams and leadership within the Analytical R&D department.
  • Candidates must have a proven track record in NDA preparation and transferring projects to commercial manufacturing.
  • Roche fosters a culture of personal expression where every voice matters and employees are valued for their unique qualities.

Matching Summary

Match Score: 85

Roche is seeking a CMC Expert with a focus on analytical development for parenterals and devices, located in Basel, Switzerland. The role emphasizes providing scientific guidance, leading complex CMC issue resolution, and mentoring within Roche's collaborative and inclusive culture.

Skills & Requirements

Must-have

  • Expert analytical development of parenterals
  • NDA preparation and regulatory submission
  • Root cause analysis for complex CMC issues
  • Mentoring scientific staff and teams
  • Cross-functional collaboration in R&D

Nice-to-have

  • Experience with oligonucleotides and peptides
  • Strategic problem-solving skills
  • Portfolio-wide risk analysis expertise
  • Passion for knowledge sharing culture

Key Requirements

  • Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences or Chemistry
  • Extensive experience in pharmaceutical R&D
  • Deep knowledge of analytical development for combination products with devices

Work Rights

Not specified

Tailored Resume

Cover Letter