Associate Director, Cell Therapy Network Investigations Lead

Overview

Associate Director, Cell Therapy Network Investigations Lead. This role supports the commercial and late-stage clinical cell therapy network for complex trend investigations stemming from deviations and SAEs. The lead investigator assembles and leads cross-functional teams to close complex trend investigations and collaborates with SMEs, user groups, quality groups, and other stakeholders.

Responsibilities

• Develop and execute standard work and communication plans for trend investigations, ensuring communication across all impacted manufacturing sites and technical stakeholders, and use consistent tools for root cause analysis, CAPA identification, and documentation.
• Serve as the interface between sites, product teams and laboratories to ensure a consistent approach to trend investigations.
• Lead global trend investigations and global SAE events.
• Support site-based investigators for complex trend investigations.
• Manage complex cross-functional projects/programs using project management techniques and tools appropriate for the project.

Qualifications & Experience

• Bachelor\'s degree or equivalent in a relevant discipline with a minimum of 8 years of relevant experience. Master\'s degree preferred (but not required). Time spent in advanced degree programs may be considered as equivalent relevant experience.
• Green Belt or Black Belt is preferred but not required.
• Expert understanding of cGMP regulations and/or business and documentation processes.
• Expert in root cause analysis, CAPA and risk mitigation.
• Proficient in project and portfolio management skills.

Compensation & Benefits

The starting compensation ranges include location-specific figures (e.g., Devens, MA; Seattle, WA; Summit, NJ) and may include additional incentive cash and stock opportunities based on eligibility. Final compensation is determined based on demonstrated experience. Benefits may include medical, dental, vision, wellbeing programs, 401(k), disability and life insurance, paid time off, volunteer days, and other programs as described on the company career site.

Additional information on benefits and equal employment opportunity is available on the careers site. Statements regarding on-site occupancy, accommodations for applicants with disabilities, and Covid-19 considerations are provided as part of the job posting.

Location

New York, NY and other eligible locations per posting.