Senior Specialist, Manufacturing NPI & Clinical Readiness

Bristol Myers Squibb • Bothell, WA

9d • $96,832 - $117,338 • Onsite

About The Position

The Senior Specialist, Manufacturing NPI and Clinical Readiness supports clinical and commercial manufacturing readiness for cell therapy products. This senior individual contributor owns manufacturing documentation and MES recipe readiness, assesses change-control impacts, coordinates clinical runs, conducts risk assessments, and supports operator training. The role works with increased independence and technical breadth, driving execution quality and ensuring processes are clearly defined, executable, and inspection-ready.

The Senior Specialist partners 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. Responsibilities include managing manufacturing documentation; representing operations in MES activities; leading readiness, risk assessment, training, and run coordination; and supporting change control and continuous improvement.

Requirements

• High school diploma required.
• Bachelor’s degree in Engineering, Life Sciences, or a related technical field, or relevant years of experience.
• 3–5 years of experience in a GMP-regulated manufacturing environment.
• Advanced working knowledge of batch record development, SOP authorship, and GMP documentation practices.
• Hands-on experience supporting MES or electronic batch record systems in a manufacturing environment.
• Strong understanding of aseptic or sterile manufacturing principles.
• Ability to independently perform and document manufacturing risk assessments.
• Experience performing change-control impact assessments and authoring or executing UAT for automated manufacturing recipes.
• Ability to coordinate cross-functional teams and lead operational huddles for clinical, engineering, and validation manufacturing runs.
• Strong technical writing skills and ability to translate complex processes into clear work instructions.
• Effective communication skills and ability to train operators and collaborate across functional teams.
• Ability to work independently, prioritize work, and manage multiple deliverables in a regulated environment.

Nice To Haves

• Cell therapy or biologics manufacturing experience.
• Prior experience with batch records, SOPs, manufacturing execution, MES systems, and operator training.

Responsibilities

• Author, revise, and manage manufacturing batch records, procedures, and SOPs for clinical manufacturing, technical transfer, and commercial readiness.
• Serve as a senior documentation subject matter expert, ensuring instructions are technically accurate, compliant, executable, and inspection-ready.
• Coordinate documentation readiness with manufacturing timelines, change-control requirements, and inspection expectations.
• Act as a point person and liaison with internal groups, including QA, QC, and Regulatory, to resolve technical and compliance issues.
• Use resources and processes, including OPEX, to improve processing efficiency and technical support for manufacturing, technical transfer, and scale-up.
• Establish and maintain schedules for people, facilities, equipment, materials, and documents to support facility throughput.
• Collaborate with IT/MES teams to design, review, test, and deploy electronic batch records and manufacturing recipes.
• Represent manufacturing operations in MES activities and ensure recipes align with approved process designs and batch records.
• Provide manufacturing input to Recipe Design Documents, ensuring recipe logic, sequencing, prompts, and data capture reflect approved processes and can be executed on the floor.
• Author, execute, and document user acceptance testing of manufacturing MES recipes, verify readiness, and resolve MES-related execution issues.
• Draft and own Balance Automated SOPs supporting MES recipes, including periodic review, revision, and lifecycle management.
• Author and own equipment Operation & Maintenance procedures aligned with equipment design, vendor requirements, and manufacturing use.
• Follow safety requirements, complete safety training and evaluations, and escalate safety concerns.
• Lead or independently perform manufacturing risk assessments, such as FMEA, and document process, quality, and execution risks.
• Work cross-functionally to define and document risk-mitigation strategies and readiness actions; identify and escalate readiness gaps.
• Perform safety risk assessments for new and modified processes, equipment, and materials, documenting controls with EHS and Manufacturing Operations.
• Lead onboarding of new materials and equipment, including documentation, system setup, training, and readiness verification before first use.
• Develop and deliver operator training on new or updated batch records, procedures, MES workflows, and manufacturing processes.
• Act as lead trainer and subject matter expert during process introductions, technical transfers, and campaign start-ups.
• Provide on-the-floor support during engineering runs and initial clinical manufacturing to help ensure successful, right-first-time execution.
• Establish and lead readiness huddles for clinical and process-validation activities, including stability, engineering, comparability, confirmatory, technical-transfer, and PPQ runs.
• Communicate run-specific differences from routine processing to Manufacturing managers and the Manufacturing Operations team before execution.
• Align cross-functionally on run interventions, in-process checks, and contingency actions, and confirm personnel, materials, and documentation readiness.
• Participate in and lead matrixed Technical Product Teams to develop technical process-improvement strategies, including presentations supporting technical plans.
• Perform change-control impact assessments for NPI Manufacturing and own 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 execution-related issues.
• Contribute to continuous improvement in documentation quality, process robustness, MES usability, and manufacturing reliability.
• Mentor junior specialists through technical guidance and sharing best practices.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and insurance offerings such as medical, dental, vision, life, and disability.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• 11 paid company holidays annually.
• Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
• Depending on eligibility, 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 may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Eligible employees may be offered discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED