Capricor Therapeutics

MSAT Associate 2

San Diego, CA

Sponsorship not specified$73k-$88kDetected 61 days ago

ExpressComplianceExcelProcess ImprovementRecruitingGMPFDA RegulatoryCell CultureCommunicationCollaborationProblem SolvingWritingMicrosoft Office

About the role

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.
Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
In this position you will act as a Subject Matter Expert (SME) across manufacturing processes, supporting technology transfer, continuous improvement, deviation investigations, and the development and revision of controlled documentation.

Providing support to MSAT Team and working cross-functionally to ensure clear communication across various departments.
Providing in-person and real-time manufacturing production support as needed.

Experience with writing/revising technical documents is required (SOPs, Forms, Batch Records, etc).
Previous experience with, or knowledge/understanding of, various quality events is required (Deviations, CAPAs, Change Controls etc).
Deep understanding of cell culture and ability to troubleshoot common processing issues.
Ability to collect and assist in the analyzation/trending of data and information to determine paths for process improvement and potential root cause.
Demonstrates technical proficiency, scientific creativity, problem-solving skills, strong GMP principles and collaboration with others.
Must have full working knowledge of cGMP regulations.
Ability to work in a dynamic environment, multi-task, and meet aggressive deadlines.
Ability to work independently, as well as work on larger cross-department projects as a team.
Ability to sit or stand for extended periods during training and operations.

Bachelor's degree and 2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry preferred, or equivalent combination of degree/experience.
A minimum of 1 year experience in adherent cell culture.
Additional experience with cells in suspension is a plus.
Experience with scale-up of cell therapy processes and closed manufacturing systems preferred.

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