Director – Technology Transfer, Formulation

PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.

Singapore
10+ years pharmaceutical development experience
5+ years cdmo environment experience
Process design & scale-up using qbd principles
Lead the design and execution of scale-up strategies for diverse dosage forms using Quality by Design principles

Job Summary

  • Lead the design and execution of scale-up strategies for diverse dosage forms using Quality by Design principles.
  • Serve as the primary technical point of contact ensuring seamless transfer of client processes to the CDMO receiving unit.
  • Author and review technical sections of regulatory filings and represent the team during Pre-Approval Inspections.

Matching Summary

Match Score: 85

Lead the design and execution of scale-up strategies for diverse dosage forms using Quality by Design principles.

Skills & Requirements

Must-have

  • 10+ years pharmaceutical development experience
  • 5+ years CDMO environment experience
  • Process Design & Scale-up using QbD principles
  • Tech Transfer Ownership for diverse dosage forms
  • cGMP and ICH guidelines (Q8, Q9, Q10, Q11) expertise
  • Statistical tools proficiency (JMP, Minitab)
  • Risk Assessment tools (FMEA) application

Nice-to-have

  • Experience with regulatory filings (IND, NDA, BLA, ANDA)
  • Representation during Pre-Approval Inspections (PAI)
  • Strong stakeholder liaison capabilities
  • Timeline management for clinical supply milestones
  • Strategic technical leadership skills

Key Requirements

  • Ph.D. or Master's degree in Pharmaceutical Sciences
  • 10+ years industry experience with 5+ in CDMO
  • 5+ years managing high-performing technical teams
  • Proven track record of commercial product launches

Work Rights

Not specified

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