( Associate) Principle Scientist - Car-t

Workatwamz

Tech transfer execution
Data integrity and compliance
Comparability study design
Lead tech transfer execution, driving risk and crisis management for on-time, high-quality transfer

Job Summary

  • Lead tech transfer execution, driving risk and crisis management for on-time, high-quality transfer.
  • Own process validation strategy and execution, including studies for chromatography resin and reusable filter lifetime.
  • Support compliance and regulatory activities by participating in GMP audits, on-site inspections, and regulatory filings.

Matching Summary

Lead tech transfer execution, driving risk and crisis management for on-time, high-quality transfer.

Skills & Requirements

Must-have

  • Tech transfer execution
  • Data integrity and compliance
  • Comparability study design
  • Process validation strategy
  • GMP audit participation

Nice-to-have

  • Inclusive and diverse team
  • Harnessing industry-leading skills
  • Broader range of perspectives

Key Requirements

  • Master’s degree or above in biological or pharmaceutical discipline
  • More than 8 years’ experience in MSAT or process development
  • Experience with NDA/BLA submissions of cell and gene therapy industry
  • Proficient in QbD, GMP and other related regulations/guidance
  • Strong statistical analysis skills
  • Strong written English and fluent oral English

Work Rights

Not specified

Tailored Resume

Cover Letter