Associate Director, Grs - Cmc, Cell Therapy

Bristol Myers Squibb

Warsaw, Poland
Base: zł361,740 - zł438,337; bonus/equity: + incen...
50% onsite
8+ years pharmaceutical industry experience
5+ years cmc regulatory strategy
Knowledge of cell therapy regulatory requirements
Bristol Myers Squibb is seeking an Associate Director for their GRS-CMC Cell Therapy team in Warsaw, Poland. This role involves providing regulatory expertise in CMC activities throughout the product lifecycle, with a focus on cell therapy products, and requires significant experience in the pharmaceutical industry

Job Summary

  • The role involves developing global regulatory CMC strategies and partnering with stakeholders to execute them in alignment with business priorities.
  • Candidates will serve as the primary interface between Global Regulatory Sciences and product development teams to assess manufacturing changes.
  • Bristol Myers Squibb offers a wide variety of competitive benefits and programs to support employees in pursuing their goals both at work and personally.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking an Associate Director for their GRS-CMC Cell Therapy team in Warsaw, Poland. This role involves providing regulatory expertise in CMC activities throughout the product lifecycle, with a focus on cell therapy products, and requires significant experience in the pharmaceutical industry.

Salary

Base: zł361,740 - zł438,337; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Wide variety of competitive benefits and programs provided

Skills & Requirements

Must-have

  • 8+ years pharmaceutical industry experience
  • 5+ years CMC regulatory strategy
  • Knowledge of cell therapy regulatory requirements
  • Experience with global regulatory submissions
  • Ability to lead matrix teams

Nice-to-have

  • Experience with small molecules and biologics
  • Strong project management skills
  • Innovative problem-solving abilities
  • Cross-functional team collaboration
  • Continuous improvement mindset

Key Requirements

  • Minimum BA/BS Degree
  • 8+ years Pharmaceutical industry experience
  • 5+ years CMC regulatory strategy knowledge
  • Expertise in cell therapy modalities
  • Proficiency with electronic systems for dossier creation

Work Rights

Not specified

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