Capricor Therapeutics

Biotech

MSATAssociate2

$73–88k San Diego, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Biotech
Problems you'll solve

Scientific problem solving; Troubleshooting; Problem-solving skills

Eligibility Requirements

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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