MSAT Associate 2

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.

Why Capricor?

Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission-driven team working at the intersection of innovation, execution, and patient impact.

Come Work With Us

At Capricor, you’ll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.

Recruiting Fraud Notice

Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by someone using an official Capricor email address ending in @capricor.com. Capricor will never ask candidates to send money, deposit a check, purchase equipment, or provide payment for any reason as part of the recruiting or onboarding process.

Notice to Recruiting Agencies

Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without express written approval from Talent Acquisition and a fully executed agreement with Capricor. Agencies that contact hiring managers directly, solicit business, or submit candidates without prior approval will not be considered for engagement. Any unsolicited submissions will become the property of Capricor Therapeutics, and no fees will be paid for candidates hired as a result of such submissions. We appreciate your cooperation and respect for this policy.