CMC Development and Strategy Project Manager

PRESTIGE BIOPHARMA LIMITED

Singapore, Singapore
Not specified
Process development expertise
Cmc regulatory requirements knowledge
Technology transfer protocols management
Prestige Biopharma Limited is seeking a CMC Development and Strategy Project Manager to oversee project management activities in the biologics space, focusing on process development milestones, regulatory submissions, and stakeholder management. The role requires strong technical expertise in CMC regulatory requirements and a collaborative approach to work with cross-functional teams and external partners

Job Summary

  • This role involves overseeing project management activities by translating process development milestones into actionable CMC timelines.
  • The successful candidate will act as the primary technical bridge between internal teams and external partners like CMOs and CDMOs.
  • Key responsibilities include drafting Quality sections of dossiers for clinical trial and marketing authorization applications while ensuring strict alignment with agency expectations.

Matching Summary

Match Score: 85

Prestige Biopharma Limited is seeking a CMC Development and Strategy Project Manager to oversee project management activities in the biologics space, focusing on process development milestones, regulatory submissions, and stakeholder management. The role requires strong technical expertise in CMC regulatory requirements and a collaborative approach to work with cross-functional teams and external partners.

Skills & Requirements

Must-have

  • Process Development expertise
  • CMC regulatory requirements knowledge
  • Technology transfer protocols management
  • Biologics scale-up experience
  • Quality section dossier authoring

Nice-to-have

  • Functional assays knowledge
  • Physiochemical characterization skills
  • Monoclonal antibody background
  • Cross-functional collaboration abilities
  • Vendor negotiation experience

Key Requirements

  • Bachelor's, Master, or PhD in scientific discipline
  • Proven track record in biologics Process Development
  • In-depth knowledge of CMC regulatory processes

Work Rights

Not specified

Tailored Resume

Cover Letter