Senior Specialist, Manufacturing NPI & Clinical Readiness

Bristol Myers Squibb • Bothell, WA

7d • Onsite

About The Position

The Senior Specialist, Manufacturing NPI and Clinical Readiness enables clinical and commercial manufacturing readiness for cell therapy products. This senior individual contributor owns manufacturing documentation, MES recipe readiness and automation, change control impact assessments, clinical run coordination, risk assessments, and operator training. The role drives execution quality, coordinates across functions, and ensures that manufacturing processes are clearly defined, executable, and inspection-ready at the JUMP Bothell site.

The Senior Specialist partners with Manufacturing Operations, MSAT, Quality, IT/MES, Engineering, Supply Chain, and other internal groups to support technical transfer, manufacturing readiness, and sustained operational performance. The role also supports process efficiency, scale-up, facility capacity planning, and continuous improvement. It reports to the Associate Director of MFG NPI and Clinical Readiness.

The schedule is Sunday through Tuesday, with alternating Wednesdays, from 8 a.m. to 8 p.m. The listed annual pay range for Bothell, Washington is $96,832–$117,338. Eligible employees may also qualify for discretionary cash incentives and stock opportunities.

Requirements

• High school diploma required.
• Three to five 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.
• Ability to train operators and collaborate effectively across functional teams.
• Ability to work independently, prioritize work, and manage multiple deliverables in a regulated environment.

Nice To Haves

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field, or equivalent relevant experience.
• Prior experience with batch records, SOPs, manufacturing execution, MES systems, and operator training.
• Cell therapy or biologics manufacturing experience.
• Experience with aseptic or sterile manufacturing, preferably in cell therapy or biologics.

Responsibilities

• Author, revise, and manage the lifecycle of manufacturing batch records, procedures, and SOPs for clinical manufacturing, technical transfer, and commercial readiness.
• Serve as a senior documentation subject matter expert, ensuring manufacturing instructions are technically accurate, compliant, executable, and inspection-ready.
• Coordinate documentation readiness with manufacturing timelines and change control requirements, and help resolve technical and compliance issues with internal groups such as QA, QC, and Regulatory.
• Use resources and operational processes to improve processing efficiency and provide technical support for manufacturing, technical transfer, and scale-up.
• Establish and maintain schedules for personnel, facilities, equipment, materials, and documents to support facility capacity and throughput.
• Partner with IT/MES teams on the design, review, testing, and deployment of 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, including recipe logic, sequencing, prompts, and data capture.
• Author, execute, and document user acceptance testing of manufacturing MES recipes; verify readiness and resolve MES execution issues.
• Draft and manage Balance Automated SOPs and equipment Operation & Maintenance procedures, including periodic review and lifecycle management.
• Follow safety requirements, complete safety training and evaluations, and escalate safety concerns.
• Lead or independently execute manufacturing risk assessments, identify process, quality, and execution risks, and partner with cross-functional teams to define and document mitigation strategies.
• Identify risks or gaps affecting batch execution, training, or MES readiness and escalate them appropriately.
• Perform safety risk assessments for new and modified processes, equipment, and materials, documenting required controls with EHS and Manufacturing Operations.
• Lead onboarding of new materials and equipment into manufacturing, including documentation, system setup, training, and readiness verification before first use.
• Develop and deliver operator training on batch records, procedures, MES workflows, and manufacturing processes.
• Act as a lead trainer and subject matter expert during process introductions, technical transfers, and campaign start-ups.
• Provide floor support during engineering runs and initial clinical manufacturing to support successful, right-first-time execution.
• Establish and lead manufacturing 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, contingency actions, and readiness of personnel, materials, and documentation.
• Participate in and lead matrixed Technical Product Teams to advance technical process improvement strategies.
• Prepare presentations supporting the development, approval, and execution of technical plans.
• Perform change control impact assessments for NPI Manufacturing and own resulting change actions.
• Support execution and closure of change controls related to documentation, MES recipes, and manufacturing readiness deliverables.
• Partner with Manufacturing Operations, MSAT, and Quality to resolve documentation- and 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 benefits may include wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance.
• Eligible U.S.-based exempt employees may receive Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays.
• Non-exempt employees, RayzeBio employees, and employees 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, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves 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 cash incentives and stock opportunities.

What This Job Offers

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