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RO
Roche
6mo ago

Senior/ Principal Scientist - Peptide parenteral formulation development(m/w/x)

Basel
Full-timeOn-siteManagement

Description

You lead the development and manufacturing of innovative peptide formulations, ensuring regulatory compliance and facilitating market approvals to provide essential medicines to patients.

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Requirements

  • •Proven experience authoring NDA drug product sections
  • •Strong expertise in chemistry and solid state characterization
  • •Experience in peptide analytical techniques and aseptic manufacturing
  • •Direct experience in writing regulatory CMC documents
  • •Excellent communication and stakeholder management skills
  • •Ph.D. or master's degree in chemistry or related fields

Education

Doctoral / PhD
OR
Master's degree

Work Experience

6 years

Tasks

  • •Drive development of peptide parenteral formulations.
  • •Oversee manufacturing processes for peptide formulations.
  • •Manage scale-up, process characterization, and validation.
  • •Facilitate transfer to global commercial manufacturing sites.
  • •Act as Pharmaceutical Project Leader in CMC teams.
  • •Shape global regulatory submissions for all phases.
  • •Impact market approvals for life-changing medicines.

Languages

English – Business Fluent

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