MSAT Associate 2

Capricor; San Diego (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Capricor in San Diego seeks an MSAT Associate 2 to support cGMP manufacturing operations through technical writing and scientific problem solving. The role involves managing quality events, acting as a Subject Matter Expert, and collaborating closely with Manufacturing, QA, and Process Development.

The ideal candidate should have a Bachelor’s degree and relevant experience in biologics manufacturing, particularly with adherent cell culture. Applicants should also demonstrate excellent communication skills and a strong understanding of cGMP regulations.

Qualifications

• 2+ years of hands-on cGMP biologics manufacturing experience in the pharmaceutical/biotech industry.
• 1 year of experience in adherent cell culture.
• Experience with writing technical documents such as SOPs and batch records.

Responsibilities

• Support MSAT Team and ensure clear communication across departments.
• Manage deviations and perform root-cause investigations.
• Assist with tech transfers into cGMP Manufacturing.

Skills

cGMP biologics manufacturing experience

Adherent cell culture

Technical writing

Data analysis

Education

Bachelor’s degree

Tools

Microsoft Word

Microsoft Excel

Job 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 orbiologics 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 the MSAT Team and working cross‑functionally to ensure clear communication across various departments.
• Managing 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 compile 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.
• Supporting the Manufacturing group and troubleshooting production activities to ensure safe, quality, and timely manufacture of biopharmaceutical products for pre‑clinical, clinical, and commercial use.
• Assisting on revising (as needed) and reviewing process‑related manufacturing documentation (batch records, SOPs, bills of material, process flow diagrams) to assure all clinical products meet the requirements for quality, safety, and efficacy.
• Providing in‑person and real‑time manufacturing production support as needed.
• Collaborating with Supplier Quality and Manufacturing to evaluate change notifications or material non‑conformances.
• Identifying continuous improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance in cross‑functional collaborations.
• Working closely with the Quality department to ensure compliance with cGMP, IC, and FDA regulations.
• Serving as an organizational change agent and fostering an atmosphere of a questioning attitude, empowerment, and an error‑prevention/continuous improvement mindset.
• Performing such other duties as may be assigned from time to time.
• Compliance with gowning procedures and cleanroom protocols for aseptic activities.
• Professional GMP facility environment with controlled conditions.
• Ability to sit or stand for extended periods during training and operations.
• Occasional lifting of materials or equipment up to 40 pounds.
• Willingness to work inside an ISO 7 cleanroom when supporting manufacturing operations.

Qualifications

• 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 writing/revising technical documents is required (SOPs, forms, batch records, etc.).
• Previous experience with, 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.
• Experience with scale‑up of cell therapy processes and closed manufacturing systems preferred.
• Ability to collect and assist in the analysis/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.
• Exceptional communication, presentation, and interpersonal skills.
• Strong Microsoft Word and Excel skills.
• 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.