Senior Director, Analytical Sciences & Cell Therapy

Bristol Myers Squibb; Harvard (MA); On-site; USD 168,000 - 205,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid holidays

Comprehensive benefits

Job summary

Bristol Myers Squibb is seeking a Scientific Associate Director to own the analytical method lifecycle for Cell Therapy within ASAT, leading validation, transfer, monitoring, and investigations across product lifecycles. You will partner with Analytical Development, QC, Manufacturing, and Regulatory Affairs to ensure compliant, innovative methods supporting quality and regulatory submissions.

You will influence strategy, lead high-risk initiatives, mentor staff, and promote digital, automated

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree (MS or PhD) preferred.
• 10+ years of relevant experience within biotechnology, pharmaceuticals, cell therapy, gene therapy, or biologics manufacturing environments.
• Demonstrated experience leading complex global analytical programs across multiple functions and sites.
• Advanced knowledge of manufacturing, quality systems, regulatory affairs, process development, and product lifecycle management.
• Extensive expertise in analytical method validation, qualification, transfer, and monitoring in GMP environments.
• Regulatory knowledge across FDA, EMA, ICH, USP, EP and cell/gene therapy regulations.

Responsibilities

• Provide technical support and guidance for method performance troubleshooting and data evaluation from internal/external labs.
• Lead analytical method validation, transfer, lifecycle management, investigations, and performance optimization.
• Coordinate matrix and cross-functional teams on high-impact analytical initiatives.
• Influence analytical strategy and implement innovative approaches aligned with long-term objectives.
• Develop scientifically sound solutions to complex analytical challenges impacting quality and compliance.
• Lead trend analysis, monitoring, and implementation of improvement actions for methods.
• Drive investigations related to deviations, OOS, OOT, and aberrant data with robust root-cause analysis.
• Partner with internal/external labs to establish analytical capabilities and ensure successful transfers/validation.
• Champion standardization initiatives across sites/products/quality functions.
• Promote digitalization, automation, and advanced technologies to enhance performance and data integrity.
• Share knowledge and best practices enterprise-wide with an enterprise product mindset.
• Author/review/approve complex technical reports, validation protocols, and regulatory submissions.

Skills

Analytical leadership

Cross-functional leadership

Method validation

Method transfer

Troubleshooting

Regulatory knowledge

Strategic thinking

Mentoring

Data interpretation

Communication

Education

MS/PhD preferred

Bachelor’s degree required

Job description

Bristol Myers Squibb is seeking a Scientific Associate Director to own the analytical method lifecycle for Cell Therapy within ASAT, leading validation, transfer, monitoring, and investigations across product lifecycles. You will partner with Analytical Development, QC, Manufacturing, and Regulatory Affairs to ensure compliant, innovative methods supporting quality and regulatory submissions.

You will influence strategy, lead high-risk initiatives, mentor staff, and promote digital, automated