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

Military Spouse Corporate Career Network•Bothell, WA

4d•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 and MES recipe readiness, supports change control impact assessments, coordinates clinical runs and readiness activities, performs risk assessments, and trains operators. The role works with increased independence and technical breadth, helping ensure that manufacturing processes are clearly defined, executable, and inspection-ready. 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 at the JUMP Bothell site. The position also supports process improvement, equipment and material onboarding, and on-the-floor execution during engineering and initial clinical manufacturing runs. The schedule is Sunday through Tuesday, with alternating Wednesdays, from 8 a.m. to 8 p.m. The position is on-site in Bothell, Washington. The listed compensation range is $96,832–$117,338, with potential eligibility 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 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.
Cell therapy or biologics manufacturing experience.
Prior experience with batch records, SOPs, manufacturing execution, MES systems, and operator training.
Experience with cell therapy or biologics.

Responsibilities

Author and manage the development, revision, and 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 act as a point person and liaison for technical and compliance issues.
Use resources and processes, including OPEX, to improve processing efficiency and technical support for manufacturing, technical transfer, and scale-up.
Ensure schedules for personnel, facilities, equipment, materials, and documents are established and maintained 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 input to Recipe Design Documents, including recipe logic, sequencing, prompts, and data capture.
Author, execute, and document user acceptance testing for manufacturing MES recipes, verify readiness, and resolve MES-related execution issues.
Draft and manage Balance Automated SOPs that support MES recipes, including periodic review and lifecycle management.
Author and manage 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 work cross-functionally to define and document mitigation strategies.
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 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 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 on-the-floor support during engineering runs and initial clinical manufacturing to promote 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 to drive technical process improvement strategies.
Generate 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- 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.