Capricor Therapeutics
Biotech
MSATAssociate2
Neural analysis suggests this role is
optimal for Mid+ candidates.
“MSAT Associate 2 at Capricor Therapeutics. Skills: CGMP manufacturing, Deviation investigations, Process troubleshooting. Support MSAT Team. Ensure clear communication”
What You'll Achieve.
Ensure compliant operations; Ensure efficient operations; Ensure well-documented operations; Ensure safe manufacture; Ensure quality manufacture; Ensure timely manufacture; Meet requirements for quality; Meet requirements for safety; Meet requirements for efficacy; Increase yield; Maximize capacity; Improve operational efficiency; Reduce costs; Ensure safety; Maintain regulatory compliance
Industry & Context.
Scientific problem solving; Troubleshooting; Problem-solving skills
Work in ISO7 cleanroom, Gowning procedures, Cleanroom protocols, Lift up to 40 pounds
What They're Looking For.
Must Have
2+ years cGMP biologics manufacturing experience, 1 year experience in adherent cell culture, Experience writing/revising technical documents, Knowledge/understanding of quality events, Full working knowledge of cGMP regulations
Nice to Have
Bachelor's degree, Equivalent combination of degree/experience, Additional experience with cells in suspension, Experience with scale-up of cell therapy processes, Experience with closed manufacturing systems
What You'll Do.
Ensure clear communication
Manage quality records
Perform root cause investigations
Evaluate product impact
Compile scientific data
Assist with tech transfers
Support manufacturing group
Troubleshoot production activities
Revise process documentation
Review manufacturing documentation
Provide real-time support
Evaluate change notifications
Evaluate material non-conformances
Identify continuous improvement opportunities
Identify corrective actions
Foster atmosphere of questioning attitude
Foster atmosphere of empowerment
Foster atmosphere of error prevention
Foster atmosphere of continuous improvement
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Partner with Manufacturing; Partner with QA; Partner with Process Development; Partner with Supplier Quality; Work with Quality department
Communication Scope
Exceptional communication; Presentation skills; Interpersonal skills
Full Job Description
## Description Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The MSAT Associate 2 supports cGMP manufacturing operations through technical writing, investigation management, and process-focused scientific problem solving. This role requires a strong understanding of cell therapy or biologics manufacturing and a demonstrated ability to analyze data, manage quality events, and provide real-time support to production activities. 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. This position partners closely with Manufacturing, QA, Process Development, and Supplier Quality to ensure compliant, efficient, and well‑documented operations. ## Responsibilities Providing support to MSAT Team and working cross-functionally to ensure clear communication across various departments. Management of deviations and other quality records, performing root cause investigations (6M, 5-Why’s, etc) to determine causal factors and evaluate product impact. Training on the cell therapy and/or exosome platforms quickly to assist in product impact assessments, and compiling scientific data relating to the manufacturing processes. Assisting with tech transfers into cGMP Manufacturing, ensuring the transfer is controlled and executed within GMP regulatory guidelines. Support
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