Bristol Myers Squibb

Therapist

• Function as an analytical expert supporting the Cellular Therapy product portfolio.
• Provide bioassay, flow cytometry and/or molecular biology analytical expertise in support of QC lab investigations.
• Support technical investigations to identify root cause and provide corrective and preventive actions, including method remediations.
• Support transfer of commercial methods and method validation in compliance with global regulatory requirements.
• Responsible for the stewardship of bioassay, flow cytometry and/or molecular methods in the Cell Therapy Quality organization.
• Implement method lifecycle and method maintenance programs to support bioassay, flow cytometry and/or molecular biology methods in support of cell therapy drug products.
• Author, revise, and review technical documents such as test methods, SOPs, trend reports, and/or investigation reports as appropriate.
• May lead project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
• May provide support in the authoring of the analytical sections of regulatory submissions, responding to health authority questions and functioning as the method validation and method transfer expert during inspections.
• Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives.
• Represent the function on cross-functional project teams.
• Perform other tasks as assigned.

Scientist, Drug Product Analytical Science and Technology, Cell Therapy

Risk

• Provide vision and define the global CAPA strategy and governance model for Research & Development by establishing standard methods, templates, taxonomies, and escalation pathways for quality events, audits/inspections, and significant non-compliances.
• Design and implement a global CAPA governance framework aligned with regulatory expectations and internal quality standards.
• Ensure CAPA processes are risk-proportionate, timely, and effective, with robust root cause analysis, sustainability checks and support risk-signal detection.
• Oversee CAPA lifecycle management, including initiation, investigation, approval, implementation, and closure.
• Drive harmonization of CAPA processes across R&D functions and ensure integration with enterprise quality systems.
• Collaborate with RDQ Global Capability Center Lead, delivering strategic leadership in supervising CAPA oversight.
• Support inspection readiness, audits, and regulatory interactions related to CAPA, as needed
• Lead continuous improvement initiatives to enhance CAPA effectiveness and cycle times.

Director, CAPA Strategy, Insights – Risk Management

• Provide strategic leadership to oversee the implementation and continuous improvement of the R&D Quality Risk Management framework, ensuring effective roll-up and reporting of risks and insights to relevant governance forums.
• Define and lead the R&D Quality Excellence and Governance strategy aligned with regulatory expectations, industry standards, and enterprise objectives.
• Ensure alignment of Quality Strategy with ICH E6(R3), ICH E8(R1), Q9, BMS Quality Plan and applicable global regulations.
• Lead the development and oversight of R&D Quality performance metrics to ensure effective consolidation and communication to Global Quality, Drug Development, Global Product Supply and Research, as applicable, in partnership with teams across RDQ.
• Partner with Corporate Quality (CQ) and Global Quality (GQ) and maintain a RDQ quality governance framework, including councils, committees, and escalation pathways.
• Monitor and report quality performance metrics, RDQ compliance dashboards and risk indicators to senior leadership and enterprise governance bodies.
• Serve as a primary liaison for GQ and Drug Development to provide executive oversight of the R&D Quality Management System (QMS), ensuring scalability, consistency, and compliance with the BMS Quality Plan.
• Champion compliance with key ICH guidelines (e.g. E6, E8, E9, Q9) and other relevant regulatory requirements.
• Drives Quality Risk Management solutions for RDQ in collaboration with RDQLT, GQ and Drug Development.
• Lead and Support the GCP serious non-compliance management process, including management of Serious Breaches, leading investigations and development of CAPA plan.
• Collaborate with Global Quality, Strategy and Business Excellence, to set goals for RDQ that are specific, measurable, achievable, relevant, and aligned to the enterprise strategies, and time bounded.
• Create a comprehensive plan that outlines the scope, timeline, resources, and key milestones for strategic initiatives taking into consideration potential risk and mitigations.

Director, Quality Excellence – Governance

Compliance

• Global Regulatory Lead for cutting edge radiopharmaceutical programs.
• Clinical and nonclinical regulatory strategy for therapeutic and diagnostic radiopharmaceutical products, including timing and nature of global regulatory interactions.
• Experience in clinical regulatory strategy in the Early Development or first-in-human space.
• Authoring of regulatory documents that are required for regulatory interactions.
• Keeping up to date in the relevant disease areas, including anticipating changes in standard of care as perceived by regulatory authorities and other key customers.
• Maintaining an expert knowledge of the relevant regulatory landscape.
• Maintaining a relationship with and representing the company to regulators.
• Lead the preparation and submission of regulatory filings (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications).
• Lead the preparation for Health Authority Interactions.
• Responsible for direct reports.

Senior Director, Regulatory Affairs – Early Development

• Identify, establish and maintain scientific relationships with Key Opinion Leaders (KOLs)
• Act as primary liaison to investigators interested in developing and performing investigator initiated research.
• Develop and execute geography-specific Field Medical and KOL Interaction plans based on therapeutic area objectives and KOL needs.
• Partner with other BMS MSL teams to achieve CTAI objectives and goals with rheumatologists and hematologists
• Support patient education initiatives, serving as subject matter expert on BMS pipeline and investigational therapies
• Provide clinical presentations and information in response to unsolicited questions (as appropriate) in academic and healthcare provider settings in both group and one-on-one situations.
• Collaborate with the Clinical research and development organization to enhance patient enrolment in BMS-sponsored clinical trials by identifying appropriate trial sites and actively interacting with participating investigators.
• Provide scientific support at National, Regional and Local medical congresses/meetings.
• Capture and provide timely feedback/insights to internal stakeholders regarding the cell therapy and autoimmune treatment landscape for strategy development.

Medical Science Liaison, Cell Therapy Autoimmune

Program Manager

• Accountable for the technical project management of MS&T’s large portfolio of biologics and small molecule CMC technical projects, with the goal to meet PDS project closure and milestone adherence metrics.
• Manage the Project Management Office (PMO) processes and Portfolio Planning activities for MS&T.
• Lead, build and sustain a high performing team of technical project managers.
• Lead monthly Portfolio Review meeting to communicate portfolio performance to MS&T leadership and gain project initiation, execution and re-baseline endorsements.
• Optimize project management & PMO practices and tools, identify and deliver digital solutions to enhance team efficiency and to reduce non-value added work.
• Collaborate with the technical strategy team, and the Technical Project Teams (TPTs) to clarify and prioritize the brand project portfolios.
• Coach project management team to ensure projects are chartered and are delivered on-time and on-budget.
• Facilitate & drive bi-annual portfolio planning processes to identify and prioritize MS&T projects, budgets, and resource requirements.
• Collaborate with ExM PMO on the project management practices for technical projects that have work scope at partner CMOs.
• Partner with business operations to manage MS&T resources.
• Partner with finance to manage, forecast, and track project spend, with the goal to meet quarterly budget targets.
• Manage department strategic projects, MS&T complex initiatives, and Technical P1 projects as needed.
• Represent MS&T PMO at GPS PMO governance forums. Influence the wider organization in effective utilization of project management tools and PMO systems.

Director, MS&T Technical Program Management

Director

• Ensure Quality Strategies for Neuroscience portfolio are developed to avoid, detect and address serious non-compliance with GCP, the trial protocol and applicable regulatory requirements to prevent recurrence.
• Oversee development of the Quality Narrative (or equivalent) at the ASSET / TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
• Manage a team of Asset Quality Leads and oversee team performance, provide guidance and development opportunities, ensuring operational efficiency and alignment with departmental and organizational objectives.
• Partner with the Drug Development organization to drive adoption of Quality by Design principles across BMS protocols to ensure quality is built into the scientific and operational design and conduct of clinical trials.
• Ensure risks to critical to quality factors are managed prospectively and adjusted when new or unanticipated issues arise once the trial has begun.
• Provide leadership, guidance, development and coaching to the R&D Risk Management team for management of significant quality issues.
• Lead for-cause, critical and/or complex quality issues as well as serious breaches for the TA, if needed.
• Provide R&D Quality expertise, critical thinking, and partner with Drug Development to deliver training and education (e.g., use cases, best practices, road shows, etc.) to support effective RBM practices.
• Establish strong partnerships with business stakeholders and participate in GPT / CDT / other relevant governance committees for the ASSET. Preferably from ID-2 (Go to Development) or ID-3 (Go to POC).
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.
• Define, own, and execute R&D Quality processes contributing to Drug Development’s end-to-end Risk Management framework across the clinical trial portfolio.
• Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.
• External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.
• Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.

Director, Development Quality Lead – Neuroscience

• Function as a molecular biology analytical expert supporting the Cellular Therapy product portfolio.
• Provide molecular biology analytical expertise in support of QC lab investigations.
• Participate in technical investigations, identifying root cause and providing corrective and preventive actions, including method remediations.
• Support transfer of commercial molecular biology methods and method validation in compliance with global regulatory requirements.
• Responsible for the stewardship of molecular biology methods in the Cell Therapy Quality organization.
• Implement method lifecycle and method maintenance programs to support molecular biology methods in support of viral vector and cell therapy drug products.
• Author, revise, and review technical documents such as test methods, SOPs, trend reports, and/or investigation reports as appropriate.
• Lead project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
• Provide support in the authoring of the analytical sections of regulatory submissions, responding to health authority questions and to function as the method validation and method transfer expert during inspections.
• Partner with development organizations in the design of development and qualification studies, selection and characterization of reagents, and method optimization initiatives.
• Represent the function on cross-functional project teams.
• Train and mentor others on molecular biology techniques, methods and procedures.
• Champion and foster a positive and successful collaborative quality culture.
• Perform other tasks as assigned.

Senior Scientist, Drug Product Analytical Science and Technology – Cell Therapy

General Counsel

• Serve as the lead legal advisor to Senior Vice President of Global Supply Chain, join their senior leadership team, advising on complex issues that arise in the supply of product across the clinical and commercial networks while working closely with Customs and Trade leads and across functions to enable the urgent delivery of medicines to patients.
• Serve as the lead legal advisor on all trade issues, inclusive of licensing, import/export laws, tariffs, sanctions, and similar trade regulations.
• Collaborate with Law & Policy Department colleagues to bring seamless and enterprise-aligned legal support to Global Supply Chain including complex supply, logistics, and transportation transactions.
• Draft, review, and negotiate complex supply chain agreements.
• Monitor evolving global regulations and enforcement trends impacting supply chain operations and trade, and proactively advise leadership on business impact and risk mitigation.

Senior Counsel, Global Supply Chain – Trade

• Lead and manage Computer System Assurance (CSA) and IT qualification efforts for systems and applications in core GxP functions – primarily Research, Commercial and Cell Therapy functions.
• Supervise junior to mid-level team members assigned to IT and Compliance programs to ensure effectiveness, efficiency, consistency, quality of work and compliance with external regulations and internal procedures.
• Collaborate with cross functional and multi-location IT Delivery teams, business users and internal Global Quality compliance staff to ensure that CSA activities are planned and executed in accordance with internal procedures.
• Evaluate, propose, and implement AI based technology solutions that improve digitization, compliance, and productivity.
• Serve as a CSA subject-matter-expert in support of internal and external regulatory inspections.
• Participate in internal and external audits and inspections, providing validation-related support and documentation.

Associate Director, IT Quality Services

• Lead research initiatives exploring foundational principles of intelligence, including reasoning, planning, memory, and generalization in AI systems.
• Architect frameworks for agent cognition, abstraction, goal decomposition, and adaptive planning; establish design principles for multi-agent systems.
• Define research hypotheses and experimental agendas that advance the lab's understanding of intelligent behavior in artificial systems.
• Synthesize academic literature and industry advances to shape the lab's technical roadmap for reasoning and cognitive architectures.
• Publish findings and represent the lab's research at internal forums and external conferences.
• Lead the development of benchmarking and evaluation science for AI agents, establishing rigorous methodologies to assess reasoning, planning, and generalization.
• Define evaluation frameworks and success criteria for multi-agent systems across diverse enterprise use cases.
• Oversee the creation of test harnesses, evaluation datasets, and measurement standards.
• Ensure experimental rigor and reproducibility across all benchmarking activities.
• Set the strategic direction for how the organization measures and validates agent intelligence.
• Lead the design and development of multi-agent AI systems using frameworks such as Strands, LangGraph, DSPy, and similar agentic architectures.
• Oversee development of RAG applications, knowledge graphs, and conversational AI solutions informed by research insights.
• Drive the implementation of autonomous workflows and decision systems that demonstrate advances in agent reasoning.
• Ensure solutions reflect the latest research in planning, memory, and generalization capabilities.

Associate Director, Intelligence Systems Lab

Manager

• Conduct research on reasoning, planning, memory, and generalization architectures for AI agents and multi-agent systems.
• Develop and test frameworks for agent cognition, including abstraction, goal decomposition, and adaptive planning.
• Contribute to the lab's understanding of foundational principles underlying intelligent behavior in artificial systems.
• Stay current with academic literature and industry advances in AI reasoning, cognitive architectures, and agent design.
• Design and execute benchmarking experiments to evaluate agent reasoning, reliability, and generalization capabilities.
• Develop evaluation methodologies for assessing AI agent performance across diverse tasks and domains.
• Serve as a hands-on AI engineer, designing, developing, and deploying advanced agentic solutions.
• Build multi-agent AI systems using frameworks such as Strands, LangGraph, DSPy, and similar agentic architectures.
• Develop RAG (Retrieval Augmented Generation) applications, knowledge graphs, and conversational AI solutions.
• Turn research concepts into working prototypes that demonstrate advances in agent intelligence.

Scientist, Drug Product Analytical Science and Technology, Cell Therapy

Director, CAPA Strategy, Insights – Risk Management

Director, Quality Excellence – Governance

Senior Director, Regulatory Affairs – Early Development

Medical Science Liaison, Cell Therapy Autoimmune

Director, MS&T Technical Program Management

Director, Development Quality Lead – Neuroscience

Medical Science Liaison, Cell Therapy Autoimmune

Medical Science Liaison, Cell Therapy Autoimmune

Medical Science Liaison, Cell Therapy Autoimmune

Senior Scientist, Drug Product Analytical Science and Technology – Cell Therapy

Senior Counsel, Global Supply Chain – Trade

Associate Director, IT Quality Services

Associate Director, Intelligence Systems Lab

Senior Manager, Intelligence Systems Lab