- Bothell, Washington, United States
- On-site
- Full-time · Senior
- $97K–$117K per year
- 3–5 years
The Senior Specialist, Manufacturing NPI and Clinical Readiness plays a key role in enabling clinical readiness for cell therapy products through ownership of manufacturing documentation, MES readiness, change control assessment, risk assessments, and operator training.
Compensation
Bothell - WA - US: $96,832 - $117,338
Responsibilities
- Author and own the development, revision, and lifecycle management of batch records, procedures, and SOPs supporting clinical manufacturing.
- Ensure documentation readiness aligns with manufacturing timelines, change control requirements.
- Act as point person for technical issues and liaison with internal groups (QA, QC).
- Improve processing efficiency and ensure optimized technical support for scale-up.
- Collaborate with IT/MES teams to support design and review of electronic batch records.
Requirements
- Bachelor’s degree in Engineering, Life Sciences or related technical field
- High School Diploma
- Nice to have: cell therapy manufacturing
- Nice to have: biologics manufacturing
- Nice to have: FMEA