Scientific Associate Director, Analytical Sciences and Technology, Cell Therapy
Bristol Myers Squibb
Bristol Myers Squibb seeks a Scientific Associate Director to lead analytical method lifecycle management within Cell Therapy, including validation, transfer, and performance optimization. The role provides technical expertise and strategic leadership across global quality initiatives, partnering with development, manufacturing, regulatory, and external stakeholders.
Responsibilities
- Lead analytical method lifecycle including validation, transfer, monitoring, and performance optimization across cell therapy products
- Provide technical leadership on complex investigations related to out-of-specification, out-of-trend, and quality deviations
- Drive matrix teams and cross-functional initiatives to implement innovative analytical solutions and continuous improvements
- Partner with internal and external laboratories to establish analytical capabilities and ensure successful method transfers
- Author and approve technical reports, validation protocols, regulatory submissions, and represent organization during inspections and audits
Requirements
- Bachelor's degree in scientific discipline; advanced degree (MS or PhD) preferred
- 10+ years biotechnology, pharmaceuticals, cell therapy, or biologics manufacturing experience
- Demonstrated leadership of complex global analytical programs across multiple functions and sites
- Extensive expertise in analytical method validation, transfer, and GMP continuous improvement
- Advanced knowledge of FDA, EMA, ICH, USP, and cell and gene therapy regulatory requirements
- Proven ability to lead matrix teams and influence technical direction with enterprise mindset
- Strong communication skills and demonstrated talent development and mentoring capabilities
$99.38k - $120.43k
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