Bristol Myers Squibb

Clinical Research

• Provide scientific expertise to design and deliver clinical studies and programs
• Design and execute assigned clinical trial activities
• Work closely with clinical team members to conduct assigned projects
• Serve as Clinical Trial Lead for one or more trials as applicable
• Lead or support trial-level activities under necessary supervision
• Co-lead study team meetings with the GDO protocol manager
• Collaborate with cross-functional study team members and external partners such as KOLs
• Seek out and enact best practices with instruction
• Provide regular and timely updates to management
• Develop protocol and ICF documents and amendments
• Present documents to governance committees and development team meetings
• Conduct literature reviews
• Submit clinical documents to the TMF
• Develop site and CRA training materials and present them at SIVs and investigator meetings
• Review clinical narratives
• Monitor clinical data for specific trends
• Develop Data Review Plans with Data Management
• Ensure CRF design supports protocol-aligned data collection with Data Management and Programming
• Submit clinical contributions to CSRs and clinical portions of regulatory documents and submissions

Senior Manager, Global Clinical Scientist – Neuroscience

Consultant

• Develop and maintain relationships with academic and community health care professionals in Washington, DC and Baltimore, MD
• Provide on-label clinical and product education for BMS hematology and oncology products through 1:1 interactions, group presentations, and remote channels
• Assess treatment and patient-management landscapes, needs, and processes with health care professionals
• Use approved CNC resources and marketing materials to present information accurately and compliantly
• Evaluate CNC activity impact and plan follow-up actions
• Respond to educational gaps and customer needs
• Monitor CNC dashboard and account data and adjust activities and business plans
• Build knowledge of treatment landscapes, products, and disease states
• Deliver approved educational speaker programs and in-services
• Provide product demonstrations and infusion support for CAR T sites starting new patients
• Train internal stakeholders on clinical, disease-area, and product-specific topics
• Participate in assigned medical congress activities
• Share clinical insights internally to support franchise strategy
• Contribute to cross-functional account and business plans
• Assist with clinically meaningful CNC programs and projects aligned with commercial strategies
• Travel approximately 50–75% of the time and interact with HCPs in public settings

Clinical Nurse Consultant

Director

• Implement, plan, and execute assigned clinical trial activities
• Serve as Clinical Trial Lead for one or more trials
• Lead, plan, and execute trial-level activities for multiple trials with minimal to moderate supervision
• Provide scientific and clinical leadership to supporting Clinical Scientists through matrix leadership
• Co-lead study team meetings with the GDO protocol manager and collaborate with cross-functional study team members
• Support clinical development planning through provision and analysis of data
• Maintain thorough understanding of assigned protocols and educate supporting team members
• Plan and lead study startup, conduct, and close-out activities
• Evaluate innovative trial designs
• Support protocol and informed consent form development, including writing, reviewing, adjudicating and resolving cross-functional comments
• Conduct site-facing activities, including training and serving as primary contact for clinical questions
• Support data generation and validation, including CRF design, clinical data review, and query resolution
• Identify clinical data trends and escalate questions to the Medical Monitor
• Develop clinical narrative plans and review clinical narratives
• Provide information for trial budget and CRO scope-of-work development
• Review site and CRA training materials and present at SIV and investigator meetings
• Support study committee activities, including DMC activities
• Draft, review, and validate clinical study reports and clinical portions of regulatory documents
• Collaborate with and serve as primary liaison to external partners for scientific advice

Associate Director, Global Clinical Science – Neuroscience

QA Engineer

• Provide QA review and approval of technical documents and Quality Management System records for Commercial GMP analytical methods for biologics and small molecule drug substances and drug products
• Review and approve GMP documentation, including analytical method validation and transfer, analytical method procedures and change controls, protocols, reports and CoAs, and procedural/supporting documents
• Collaborate with analytical and operational functions to determine resolutions or CAPAs for protocol deviations and exceptional conditions
• Communicate, share, and escalate issues within the AQA team for consensus resolution
• Perform Quality approval of QMS records, including change controls, CAPAs, standalone actions, and effectiveness checks
• Assist in developing and implementing continuous improvement initiatives for Quality and QC functions

Manager, Analytical Quality Assurance

Procurement

• Execute category strategy activities under the guidance of performance, operations, and strategic category leaders
• Perform value analysis on costs and supplier quotes
• Recommend process improvements for efficiency
• Manage day-to-day supply issues and communicate information to internal customers and suppliers
• Support PO conversion and other non-transactional tasks
• Communicate issues to leadership and drive resolution
• Manage PO changes and communicate trends
• Participate in an orientation covering company structure, products, and brands
• Work on impactful projects supporting Bristol Myers Squibb medicines
• Participate in coaching, developmental feedback, teambuilding, networking, and exposure to senior leadership

Summer Intern – Global Procurement

• Own and continuously improve the stage-gate model, decision criteria, and governance cadence used by Program Managers
• Design and standardize core PM system processes, including governance, risk registers, decision logs, and integrated timeline templates
• Facilitate cross-functional process design sessions with clinical, regulatory, CMC, and nonclinical stakeholders
• Identify process and system gaps and inconsistencies across programs and therapeutic areas
• Lead root-cause analysis when governance breaks down
• Maintain a version-controlled library of SOPs, playbooks, and process documentation with regulatory-audit readiness where applicable
• Design and deliver onboarding curricula for new program managers
• Build job aids, quick-reference guides, and role-based training paths
• Lead change management for process and system rollouts, including impact assessments, communications, training, adoption tracking, and feedback loops
• Establish and chair a practitioner steering group
• Track adoption metrics and report process health to leadership
• Represent PM process and enablement needs in the broader PM Systems & Infrastructure roadmap
• Escalate PM-facing process changes required by IT, Quality, or Regulatory

Director, PM Systems – Infrastructure

• Develop and implement North America logistics strategies across Clinical, Commercial, and Cell Therapy modalities
• Monitor external trends and industry best practices to drive continuous process improvement
• Lead cross-functional projects, change controls, and multi-modality logistics initiatives
• Oversee North America network operations and close performance gaps with functional leads
• Report progress, risks, and outcomes to NA GLS senior leadership
• Harmonize processes, procedures, SOPs, work instructions, and operating models across modalities
• Map and integrate system workflows across the North America logistics environment
• Partner with IT and digital teams to design interoperable workflows
• Define and maintain service-level segmentation criteria balancing risk, cost, and criticality
• Own the North America logistics performance framework
• Define, monitor, and report KPIs; maintain visibility tools and dashboards
• Support budget and expense management through reporting, analysis, and actuals-versus-plan monitoring
• Lead monthly and quarterly performance review cadences
• Identify performance gaps, implement corrective actions, and track resolution
• Serve as organizational operations partner, informal escalation point, and trusted advisor to NA logistics leadership
• Prepare governance materials and leadership presentations
• Champion digital and AI enablement across the logistics organization
• Serve as subject matter expert for SAP logistics workflows and processes
• Develop and deliver SAP and process training programs
• Lead automation and operational visibility initiatives
• Assess outsourcing opportunities and develop recommendations
• Lead knowledge management efforts and centralize modality-specific logistics knowledge
• Foster relationships with global and regional stakeholders
• Develop stakeholder communication plans for major operational changes and implementations
• Represent NA GLS Modality Integration in cross-functional and global forums

Associate Director, GLS NA Modality Integration

• Define and maintain the enterprise sterility and microbial failure mode library, risk classification taxonomy, contamination event typology, and risk-based sampling strategies
• Establish and own the enterprise-wide contamination control strategy aligned with EU Annex 1, FDA Aseptic Processing Guidance, and ICH Q9/Q10
• Develop and standardize risk assessment methodologies and tools across global manufacturing sites
• Perform global microbial risk assessments of internal sites and build remediation action plans
• Review and sign off on quality decisions impacting sterility assurance across the BMS network
• Serve as escalation point for complex microbial and contamination-related quality events involving facilities, equipment, and utilities
• Author technical Business Technical Assessments and inspection-ready investigation materials
• Support regulatory inspections as a technical resource for FDA, EMA, PMDA, and other health authorities
• Lead or support CAPA development and effectiveness monitoring for systemic contamination trends
• Define and govern the enterprise APS/media fill strategy and partner with site aseptic teams
• Oversee the enterprise smoke study program and review airflow outcomes in critical zones
• Establish qualification and requalification frameworks for aseptic filling operations
• Define manufacturing process and equipment design standards for sterilization and microbial control
• Author standards for sterilization of Single-Use Technologies and consumables, including extractables/leachables and biocompatibility risk assessments
• Provide hygienic equipment design leadership to Quality, Engineering, and MS&T teams
• Support internal and external technology transfers with aseptic process and contamination control expertise
• Coordinate microbial assessments of internal manufacturing sites and identify systemic risk areas
• Conduct hygienic practice reviews of production environments and quality control laboratories
• Drive continuous improvement using environmental monitoring trends, contamination investigations, and industry benchmarks
• Provide aseptic and microbial control-by-design oversight for facility, utility, equipment, and process changes
• Provide subject matter expertise to external manufacturers investing in new technologies
• Engage in capital project, cleanroom, and major equipment design reviews
• Review and approve change controls with microbial or sterility assurance impact
• Drive innovation in aseptic processing, barrier systems, automation, and digital/AI-enabled environmental monitoring and trend analytics

Senior Director, Aseptic Process – Design

• Review and approve global risk assessments and quality impact assessments related to contamination events and microbial control failures around Facilities & Utilities
• Lead and author complex Business Technical Assessments for regulatory submissions, systemic issue resolution, and cross-site technical alignment
• Develop investigation and inspection-readiness materials for systemic aseptic and microbial control issues
• Serve as a subject matter expert on Facilities & Utilities during FDA, EMA, and other health-authority inspections
• Serve as Global Quality SME for aseptic facility and utility design
• Review and approve design packages, URSs, DQ protocols, and change controls for cleanrooms, barrier systems, and critical utilities
• Define and maintain enterprise Quality standards for aseptic facility and utility design
• Provide by-design oversight for facility, utility, and equipment changes to control microbial and particulate contamination risks
• Serve as technical authority during capital projects, facility modifications, and technology transfers
• Provide Quality oversight for WFI, Purified Water, clean steam, clean compressed gases, and HVAC/clean-air systems
• Partner with Engineering and Validation on IQ/OQ/PQ qualification programs
• Champion Quality by Design and risk-based thinking across facility and equipment lifecycle management
• Oversee aseptic facility and utility design standards at ExM partners, including CMO/CDMO facility packages, CCS documentation, and utility qualification strategies
• Support ExM facility and utility design risk assessments and drive remediation through quality governance
• Own enterprise design standards for sterilization technologies, single-use technology, and consumable qualification
• Define sterilization validation requirements and risk-based bioburden control strategies
• Ensure sterilization design standards remain current with regulatory guidance and industry best practices
• Partner across Quality, Operations, MS&T, Regulatory, and Supply Chain

Associate Director, Aseptic Facility and Utility Design

Compliance

• Execute the enterprise regulatory intelligence and surveillance program for aseptic processing, contamination control, and microbial quality
• Monitor, analyze, and interpret global regulations, guidance documents, and Health Authority expectations
• Update global procedures based on regulatory assessments
• Conduct regulatory change impact assessments and draft change notification packages
• Escalate significant compliance gaps and emerging regulatory risks
• Maintain regulatory intelligence deliverables, gap assessments, applicability matrices, horizon-scanning summaries, and compliance position papers
• Support Health Authority and industry engagement, inspections, agency inquiries, and regulatory filings related to CCS/SA
• Own commercial CCS/SA governance documentation, global procedures, policies, and standards
• Drive adoption of enterprise standards with site quality teams across manufacturing environments
• Support the transition to a unified enterprise CCS/SA function, including workforce transition planning and role definitions
• Lead inspection readiness activities across the commercial manufacturing network
• Develop inspection-ready documentation, site compliance assessments, and regulatory response materials
• Provide technical compliance support for regulatory interpretation, microbiological data integrity, critical investigations, and inspection readiness
• Coordinate science-based responses with site quality and cross-functional partners
• Contribute to the enterprise CCS/SA roadmap and maintain site-level compliance performance monitoring
• Define CCS/SA minimum requirements and decision frameworks across the BMS commercial manufacturing network
• Establish CCS/SA standards in CMO/CDMO quality agreements and coordinate external partner oversight
• Support compliance assessments and audits of external manufacturing partners
• Drive cross-site learning, community of practice initiatives, and standardized approaches across the PDS network
• Develop and maintain aseptic training content, qualification frameworks, and competency assurance tools
• Foster aseptic discipline, contamination awareness, and quality mindset
• Coordinate with PD Micro on new technologies and intersections between MQSA and PD activities
• Participate in regulatory agency, industry consortium, and professional organization engagement and benchmarking
• Represent MQSA in benchmarking initiatives and emerging science forums

Associate Director, MQSA Regulatory Intelligence and Standards

• Design and develop aseptic manufacturing processes, including fill/finish operations and sterile processing systems
• Define cleanroom layouts, material/personnel flows, and environmental control strategies to minimize contamination risks
• Support sites in evaluating and selecting aseptic manufacturing equipment and technologies, including filling lines, isolators, RABS, and sterilization systems
• Establish microbial critical process parameters and develop robust aseptic manufacturing formulas
• Lead process optimization to improve yield, reliability, and sterility assurance
• Support scale-up and technology transfer from development to commercial manufacturing
• Support or lead commissioning and qualification (IQ/OQ/PQ) of aseptic systems and production lines
• Develop and execute process validation strategies, including media fills and continued process verification
• Ensure processes remain in control through lifecycle monitoring and continuous improvement
• Define enterprise APS/media fill strategy, including governance, intervention classification, acceptance criteria, and continuous improvement expectations
• Provide expert oversight and standardization of smoke study program design and execution
• Establish and maintain enterprise policies governing media fill frequency, unit operation coverage, failure investigations, and remediation pathways
• Facilitate cross-site learning and consistency in APS program design across the BMS network
• Support sites in integrating Contamination Control & Sterility requirements into process design and operational practices
• Assess microbial contamination risks and define mitigation strategies
• Integrate environmental monitoring, cleaning validation, and sterilization practices into process design
• Ensure compliance with cGMP, FDA, EU GMP Annex 1, ISO standards, and ICH guidelines
• Support regulatory submissions, inspections, and audits with technical documentation
• Develop SOPs and technical documentation and provide input on aseptic-process batch records
• Assist sites with inspection-readiness materials and serve as a technical SME during regulatory inspections
• Partner with Quality, Manufacturing, Engineering, MS&T, and Validation teams
• Provide SME support for troubleshooting and deviation investigations
• Lead or contribute to capital projects, technology transfers, and process improvements

Associate Director, Aseptic Process and Design

• Establish and lead the global governance model for Environmental Monitoring across biologics and cell therapy manufacturing sites
• Define harmonized EM standards, procedures, sampling strategies, monitoring frequencies, limits, escalation pathways, and data review processes
• Lead network-level EM data trending and governance, including cross-site comparisons and systemic signal identification
• Develop a global approach for trend evaluation, excursion categorization, impact assessment, mitigation planning, CAPA linkage, and effectiveness monitoring
• Translate EM signals into risk assessments, mitigation plans, contamination-control improvements, and governance decisions
• Coordinate cross-site responses to significant or recurring EM excursions
• Serve as global environmental monitoring subject matter expert during investigations, contamination events, facility start-up, transfers, product introductions, readiness reviews, and inspections
• Ensure site EM programs align with global Contamination Control Strategy and aseptic, qualification, cleaning, gowning, and process-risk expectations
• Partner with sites to evaluate environmental signals against operations, flows, interventions, cleaning, HVAC, maintenance, and process design
• Lead global EM trend review boards, contamination control councils, escalation meetings, and network health reviews
• Establish metrics and dashboards for EM program health, excursion rates, investigations, CAPA effectiveness, recurrence, and inspection readiness
• Support regulatory inspections and internal audits by presenting the global EM program and governance approach
• Provide leadership, coaching, and technical guidance to QC microbiology, EM coordination, Quality, and cross-functional stakeholders
• Evaluate and implement global digital EM systems, LIMS/MODA platforms, electronic trending tools, dashboards, data standards, and integrity controls
• Support network expansion, product introduction, technology transfer, facility modification, process changes, and validation activities
• Monitor evolving regulatory expectations and industry best practices and translate them into network standards

Associate Director, Environmental Monitoring Program Coordination

Events

• Support complex microbiological and sterility assurance investigations at BMS internal manufacturing sites, including environmental monitoring excursions, sterility test failures, and process-related contamination events
• Serve as the MQSA SME for microbiological and aseptic process impact assessments
• Evaluate root cause analyses and assess product, process, and patient impact
• Review and formally sign off on impact assessments, investigation reports, CAPA records, and deviation documentation
• Partner with site Investigation Leads to ensure investigation scope, RCA depth, and CAPA effectiveness address microbiological and aseptic process risk
• Lead rapid containment and triage for sterility breaches, leaks, mold recoveries, and contamination events
• Track and trend impact assessment outcomes to identify systemic issues and emerging risks
• Support regulatory agency inspections and audits related to impact assessment findings and sterility assurance
• Serve as technical liaison for External Manufacturing partners on sterility and microbiological investigations
• Review ExM impact assessments and investigation reports and provide feedback on risk evaluation and CAPA responses
• Support CMO quality risk assessments and periodic reviews of aseptic processing, contamination control, and microbiological data trends
• Design and implement standardized CMO oversight tools, dashboards, and decision trees
• Participate in remote and on-site technical reviews with CMOs during escalated events or regulatory commitments
• Participate in CMO site assessments and vendor selection; serve as technical SME on External Manufacturing quality audit teams
• Provide expertise on barrier technology, cleanroom design, gowning programs, and aseptic technique qualification
• Support aseptic process simulations/media fills, process validation, and revalidation activities
• Contribute to contamination control strategies aligned with EU GMP Annex 1 (2022)
• Review aseptic process change controls and provide risk-based SME input
• Support cGMP improvements and regulatory guidance interpretation
• Consult on microbial sampling during technology transfers and qualification activities
• Author and approve CMC documents for process validation P.3.5 sections
• Support CMC queries and resolutions with Global Health Authorities and support plant inspections
• Mentor site-level microbiologists and quality professionals
• Contribute to global MQSA standards, SOPs, guidance documents, and training materials
• Monitor industry trends, regulatory updates, and scientific literature
• Represent MQSA in cross-functional teams, steering committees, and governance forums
• Interface with BPOG, ISPE, and PDA industry consortiums

Senior Manager, Contamination Events and Investigations

• Support microbiological and aseptic process impact assessments for internal manufacturing investigations, including environmental monitoring excursions, bioburden failures, sterility test failures, and aseptic process deviations
• Evaluate root cause analyses and contribute to product, process, and patient impact assessments under senior scientist guidance
• Author and contribute to impact assessment documentation, deviation records, and CAPA reviews
• Track action items and CAPA effectiveness with site Investigation Leads
• Monitor and trend microbiological data to identify contamination signals and systemic issues
• Collaborate with Microbiology, Quality, MS&T, Manufacturing, and Validation teams
• Prepare documentation and provide technical input for regulatory inspections and internal audits
• Review and assess sterility and microbiological investigation impact assessments from external manufacturing partners
• Provide technical input on external manufacturing assessment quality and root cause adequacy, escalating risks and gaps
• Support quality risk assessments and periodic risk reviews at CMOs/CDMOs
• Participate in remote or on-site technical interactions with external manufacturing partners
• Support environmental monitoring program reviews, cleanroom classification, and gowning qualification
• Contribute to contamination control strategy development and maintenance aligned with EU GMP Annex 1 and ICH Q9
• Support aseptic process change control reviews and cGMP improvements
• Develop and maintain SOPs, guidance documents, and training materials
• Stay current with regulatory guidance and share learnings
• Participate in cross-functional projects, working groups, and sterility assurance and microbiology forums
• Develop technical expertise in aseptic manufacturing, contamination control, and investigation methodology

Manager, Contamination Events – Sterility Assurance Support

• Own and maintain the enterprise CCS/SA governance framework, including standards, policies, procedures, and Global Procedural Oversight documents
• Provide site Environmental and Aseptic Control governance and oversight
• Define and continuously improve enterprise contamination control requirements and risk methodologies
• Govern compliance gap assessments and applicability matrices across the manufacturing network
• Drive adoption of enterprise standards into site-level operations
• Define the enterprise aseptic and microbial control roadmap, strategic objectives, KPIs, and performance monitoring frameworks
• Own the enterprise contamination control strategy, CCS frameworks, and harmonization roadmap
• Evaluate emerging aseptic processing and microbial control technologies and drive innovation adoption
• Provide centralized technical oversight across internal sites and contract partners
• Govern regulatory intelligence and surveillance programs and interpret evolving global regulations
• Lead change notifications, compliance alignment, and regulatory change impact assessments
• Lead enterprise regulatory engagement with health authorities and industry bodies
• Provide regulatory interpretation support for internal audits and regulatory inspections
• Support inspection readiness at internal manufacturing facilities and contract manufacturers
• Provide technical compliance support for regulatory interpretation, microbiological data integrity, critical investigations, and inspection readiness
• Serve as an enterprise escalation point for complex or high-risk microbial and sterility assurance matters
• Define contractual and quality agreement requirements for CMO/CDMO aseptic practices and microbial control obligations
• Oversee compliance assessments and audits of external manufacturing partners
• Govern aseptic training, capability development, and competency assurance programs
• Maintain and improve the global aseptic training program, content library, and qualification frameworks
• Foster aseptic discipline, contamination awareness, and quality mindset across the manufacturing network
• Lead external engagement with regulatory agencies, industry consortia, and professional organizations
• Represent BMS in benchmarking initiatives and emerging science forums