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

VetJobs•Bothell, WA

6d•$96,832 - $117,338•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 works independently across a broad technical scope, drives execution quality, coordinates cross-functional teams, and ensures processes are clearly defined, executable, and inspection-ready. The position partners with Manufacturing Operations, MSAT, Quality, IT/MES, Engineering, and Supply Chain at the JUMP Bothell site to support technical transfer, manufacturing readiness, and sustained operational performance. It reports to the Associate Director of MFG NPI and Clinical Readiness. The schedule is Sunday–Tuesday and alternating Wednesday, 8 a.m.–8 p.m.

Requirements

High school diploma required.
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.
Demonstrated ability to independently perform and document manufacturing risk assessments.
Experience performing change control impact assessments and authoring or executing UAT for automated manufacturing recipes.
Demonstrated ability to coordinate cross-functional teams and lead operational huddles supporting 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

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

Responsibilities

Author, revise, and manage manufacturing batch records, procedures, and SOPs supporting 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 liaise with internal groups such as QA, QC, and Regulatory to resolve technical and compliance issues.
Use resources and processes such as OPEX to improve processing efficiency and technical support for manufacturing, technical transfer, and scale-up.
Establish and maintain schedules for personnel, facilities, equipment, materials, and documents to support facility throughput.
Collaborate 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 provide manufacturing input to Recipe Design Documents, ensuring recipe logic, sequencing, prompts, and data capture reflect approved processes.
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 execute manufacturing risk assessments, such as FMEA, and partner with cross-functional teams to document mitigation strategies and readiness actions.
Identify and escalate risks or gaps affecting batch execution, training, or MES readiness.
Perform safety risk assessments for new or 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, technology transfers, and campaign start-ups.
Provide on-the-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, and contingency actions, and confirm readiness of personnel, materials, and documentation.
Participate in and lead matrixed Technical Product Teams, develop technical process improvement strategies, and generate 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 controls 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.