Cellares

Senior Quality Validation Specialist

Bridgewater, NJ · Senior

Sponsorship not specified$90k-$210kDetected 55 days ago

GMPCRISPR

About the role

Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet total patient demand for cell therapies at global scale.
Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey.

Review and approve complex documentation in support of GMP operations at the IDMO, including but not limited to facility plans, validation, CSV and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
Author and maintain the IDMO Site Validation Plan
Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge
Collaborate with stakeholders within and outside of the IDMO Facility, and communicate equipment, facility and system status
Drive continuous improvement and increase efficiency and productivity
Collaborate with stakeholders within and outside of the IDMO Facility, and communicate equipment, facility and system status; monitor progress and issue status reports
The Quality Validation team at our IDMO Bridgewater facility will be responsible for providing Quality Assurance oversight of environmental, equipment (analytical and production), facility & utility, site automation, process validation & engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities.
This individual will work closely with cross-functional teams to maintain high standards of quality in a regulated environment.

Bachelor's degree in a scientific or engineering discipline
5 to 8 years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
2+ years of direct experience in quality or validation, and demonstrated knowledge of relevant cGMP regulations
Excellent knowledge of the regulations for biologics, cell and gene therapy products
Strong knowledge of current Good Manufacturing Practices (GMP)
Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy

We are seeking an innovative and highly motivated Senior Quality Validation Specialist, who will contribute significantly to the growth of the Cellares team.

This listing is sourced directly from Cellares's careers page and normalized into a canonical job model.