Senior Specialist, Manufacturing NPI & Clinical Readiness

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a 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 entry‑level specialist roles, serving as a senior individual contributor who drives execution quality, coordinates across functions, and ensures manufacturing processes are clearly defined, executable, and inspection‑ready. 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 MES‑related 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 cross‑functional 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 start‑ups. Provide on‑the‑floor support during engineering runs and initial clinical manufacturing to ensure successful execution and right‑first‑time 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 run‑specific 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 cross‑functionally on the interventions, in‑process checks, and contingency actions required for each run, and confirm readiness of personnel, materials, and documentation so runs execute smoothly and right‑first‑time. Cross‑Functional 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 execution‑related issues. Contribute to continuous improvement initiatives focused on documentation quality, process robustness, MES usability, and manufacturing reliability. Mentor junior specialists through technical guidance and best‑practice sharing. Reporting Relationship The Sr. Specialist reports to the Associate Director of MFG NPI and Clinical Readiness. Qualifications Specific Knowledge, Skills, Abilities: o    Advanced working knowledge of batch record development, SOP authorship, and GMP documentation practices. o    Hands‑on experience supporting MES/electronic batch record systems in a manufacturing environment. o    Strong understanding of aseptic or sterile manufacturing principles, preferably within cell therapy or biologics. o    Demonstrated ability to independently perform and document manufacturing risk assessments. o    Experience performing change control impact assessments and authoring or executing UAT for automated manufacturing recipes. o    Demonstrated ability to coordinate cross‑functional teams and lead operational huddles in support of clinical, engineering, and validation manufacturing runs. o    Strong technical writing skills and ability to translate complex processes into clear work instructions. o    Effective communicator with the ability to train operators and collaborate across functional teams. o    Proven ability to work independently, prioritize work, and manage multiple deliverables in a regulated environment. Education/Experience/ Licenses/Certifications: o    Bachelor’s degree in Engineering, Life Sciences, or related technical field preferred or relevant years of experience. High School Diploma is required. o    3–5 years of experience in a GMP‑regulated manufacturing environment. o    Prior experience with batch records, SOPs, manufacturing execution, MES systems, and operator training strongly preferred. o    Cell therapy