Position SummaryThis role is accountable for the analytical method lifecycle within the Cell Therapy Analytical Sciences and Technology (ASAT) organization, including method validation, method transfer, monitoring, investigations, and continual performance optimization. The individual serves as a technical expert in analytical sciences, providing strategic and scientific leadership for complex programs across the product lifecycle.
This position influences analytical strategy, technical direction, and execution in support of Cell Therapy Global Quality objectives. The role partners closely with Analytical Development, Commercial QC, Manufacturing, Regulatory Affairs, and external partners to ensure robust, compliant, and innovative analytical methods that support product quality, regulatory submissions, and inspections.
Duties/Responsibilities- Provide technical support and guidance as needed in support of method performance troubleshooting, evaluation of analytical test methods and data generated by internal and external laboratories, including investigations related to out of specification, out of trend, and aberrant results.
- Serve as the technical lead and SME for analytical method validation, transfer, lifecycle management, investigations, and performance optimization across Cell Therapy products.
- Lead matrix teams and cross-functional technical teams on complex, high-risk, and high-value initiatives related to analytical methods, product lifecycle management, and quality improvement.
- Influence analytical strategy and technical direction by identifying and implementing innovative approaches that support long-term functional and organizational objectives.
- Develop and implement scientifically sound solutions to highly complex and novel analytical challenges impacting product quality, regulatory compliance, and operational performance.
- Lead method lifecycle, including trend analysis, method monitoring, and implementation of improvement actions.
- Drive analytical investigations associated with deviations, OOS, OOT, atypical data, method failures, and emerging quality signals, ensuring robust root cause analysis and sustainable corrective actions.
- Partner with internal and external laboratories to establish and maintain analytical capabilities while ensuring successful method transfers and validation activities.
- Champion continuous improvement initiatives and standardization efforts across sites, products, and quality functions.
- Promote digitalization, automation, and innovative technologies to enhance analytical performance, efficiency, data integrity, and compliance.
- Share technical knowledge and best practices across the organization and foster collaboration through an enterprise product mindset.
- Author, review, and approve complex technical reports, validation protocols, method transfer packages, regulatory submissions, and Health Authority responses.
- Represent ASAT during inspections, audits, regulatory interactions, and cross-functional governance forums.
- Mentor and develop scientists and technical staff while actively promoting scientific, operational, and quality excellence across the organization.
Reporting RelationshipThis position will report to the Director of Drug Product Analytical Sciences and Technology (ASAT), Cell Therapy.
Qualifications- Bachelor's degree in a scientific discipline required; advanced degree (MS or PhD) preferred.
- 10+ years of relevant experience (or equivalent combination of education and experience) within biotechnology, pharmaceuticals, cell therapy, gene therapy, or biologics manufacturing environments.
- Demonstrated experience leading complex global analytical programs and providing scientific leadership across multiple functions and sites
- Advanced knowledge of related disciplines including manufacturing, quality systems, regulatory affairs, process development, and product lifecycle management.
- Extensive expertise in analytical method validation, qualification, transfer, comparability assessments, performance monitoring, and continuous improvement in a regulated GMP environment.
- Advanced understanding of regulatory requirements and industry guidance including FDA, EMA, ICH, USP, EP, and applicable cell and gene therapy regulations.
- Demonstrated ability to influence technical direction and execute analytical strategies that support the long-term goals of Global Quality and Cell Therapy organizations.
- Proven success leading matrix teams, technical teams, or major functional initiatives involving multiple stakeholders, sites, and external partners.
- Strong ability to make decisions requiring development of new options and innovative solutions for highly complex scientific and operational challenges.
- Demonstrated enterprise mindset with a track record of sharing resources, knowledge, and best practices across a diverse network of stakeholders.
- Ability to mentor, develop talent and foster a culture of scientific, operational, and quality excellence.
- Strong business acumen with the ability to balance scientific rigor, compliance requirements, operational objectives, and business priorities.
- Demonstrated leadership and management skills, including establishing strategic direction and goals, and guiding execution while fostering a team-based environment.
- Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences including ability to interpret and author general, technical, and complex business documents.
- Advance ability to communicate effectively with peers, department management, cross-functional peers.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Devens - MA - US: $168,930 - $204,702Seattle - WA: $173,660 - $210,439Summit West - NJ - US: $157,880 - $191,312
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
