Overview
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.
- Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, and timely manufacture of biopharmaceutical product 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 Quality department to ensure compliance with cGMP, ICH 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 to you from time to time.
Requirements
- 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, 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.
- Experience with scale-up of cell therapy processes and closed manufacturing systems preferred.
- 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.
- 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.
Work Environment & Physical Demands
- 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 ISO7 cleanroom when supporting manufacturing operations.
- Compliance with gowning procedures and cleanroom protocols for aseptic activities.
