Senior Specialist, Manufacturing NPI & Clinical Readiness-Bothell, WA

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At Bristol Myers Squibb our employees often ask Who are you working fora question that fuels collaboration accountability and urgency in our work. Our purpose-driven culture inspires us to discover develop and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work opportunities for growth and a supportive environment that values inclusion wellbeing flexibility and comprehensive benefits. This is work that transforms the lives of patients and the careers of those who do it.

Position Summary

The Senior Specialist Manufacturing NPI and Clinical Readiness plays a key role in enabling clinical and commercial manufacturing readiness for cell therapy products through ownership of manufacturing documentation MES recipe readiness and automation change control impact assessment clinical run coordination risk assessments and operator training.

This role operates with increased independence and technical breadth compared to entrylevel specialist roles serving as a senior individual contributor who drives execution quality coordinates across functions and ensures manufacturing processes are clearly defined executable and inspectionready.

The Senior Specialist partners closely with Manufacturing Operations MSAT Quality IT/MES Engineering and Supply Chain to support technical transfer manufacturing readiness and sustained operational performance at the JUMP Bothell site.

Duties/Responsibilities

Manufacturing Documentation & Readiness

Author and own the development revision and lifecycle management of manufacturing batch records procedures and SOPs supporting clinical manufacturing technical transfer and commercial readiness.
Serve as a senior documentation SME to ensure manufacturing instructions are technically accurate compliant and executable on the floor.
Ensure documentation readiness aligns with manufacturing timelines change control requirements and inspection expectations.
Act as point person for technical and compliance issues and liaison with internal groups (QA QC Regulatory etc.) to facilitate issue resolution.
Employment of resources and processes (OPEX etc.) to improve processing efficiency and to ensure optimized technical support for manufacturing technical transfer and scale-up of processes to commercial scale.
Ensuring the schedules of the people facility equipment materials and documents are established and maintained to support the capacity throughput of the facility.
Collaborate closely with IT/MES teams to support design review testing and deployment of electronic batch records and manufacturing recipes.
Serve as a business/operations representative for MES activities ensuring recipes align with approved process designs and batch records.
Provide manufacturing input into Recipe Design Documents (RDDs) ensuring recipe logic sequencing prompts and data capture reflect the approved process and are executable on the floor.
Author execute and document user acceptance testing (UAT) of manufacturing MES recipes including readiness verification and resolution of MESrelated execution issues.
Draft and own the Balance Automated SOPs supporting MES recipes including periodic review revision and lifecycle management.
Author and own equipment Operation & Maintenance (O&M) procedures ensuring alignment with equipment design vendor requirements and manufacturing use.
Follows safety requirements completes safety trainings evaluations and escalates safety concerns.
Risk Assessments Equipment & Process Readiness

Lead and/or independently execute manufacturing risk assessments (e.g. FMEA or equivalent) to identify process quality and execution risks.
Partner with crossfunctional teams to define and document mitigation strategies and readiness actions.
Proactively identify risks or gaps impacting batch execution training or MES readiness and escalate appropriately.
Perform safety risk assessments for new and modified processes equipment and materials and document the controls required in partnership with EHS and Manufacturing Operations.
Lead onboarding of new materials and equipment into manufacturing including documentation system setup training and readiness verification prior to first use.
Training & Manufacturing Execution Support

Develop and deliver operator training on new or updated batch records procedures MES workflows and manufacturing processes.
Act as a lead trainer and subject matter expert during process introductions tech transfers and campaign startups.
Provide onthefloor support during engineering runs and initial clinical manufacturing to ensure successful execution and rightfirsttime performance.
Clinical Run Coordination & Readiness Huddles

Establish and lead manufacturing readiness huddles for clinical and process validation activities including stability runs engineering runs comparability runs confirmatory runs technical transfer runs and PPQ.
Communicate runspecific differences from routine processing including changes to process parameters sampling materials equipment and documentation to Manufacturing managers and the Manufacturing Operations team in advance of execution.
Define and align crossfunctionally on the interventions inprocess checks and contingency actions required for each run and confirm readiness of personnel materials and documentation so runs execute smoothly and rightfirsttime.
CrossFunctional Support & Continuous Improvement

Participate and lead matrixed Technical Product Teams to drive technical process improvement strategies. Must generate presentations to support development approval and execution of technical plans
Perform change control impact assessments on behalf of NPI Manufacturing and own the execution of resulting change actions.
Support execution and closure of change control activities related to documentation MES recipes and manufacturing readiness deliverables.
Partner with Manufacturing Operations MSAT and Quality to resolve documentation or executionrelated issues.
Contribute to continuous improvement initiatives focused on documentation quality process robustness MES usability and manufacturing reliability.
Mentor junior specialists through technical guidance and bestpractice sharing.
Reporting Relationship

The Sr. Specialist reports to the Associate Director of MFG NPI and Clinical Readiness.

Required Experience:

Senior IC