Capricor Therapeutics, Inc. · 1 month ago
MSAT Associate 2 (Tech Transfer and Process Optimization)
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$72K/yr - $88K/yr
2+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The MSAT Associate 2 will support CMC operations focusing on process development, technology transfers, and ensuring compliance with GMP regulations while collaborating across various departments to enhance manufacturing processes.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Providing support to MSAT Team and working cross-functionally to ensure clear communication across various departments
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
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
Assisting with technology transfers into cGMP Manufacturing, ensuring the transfer is controlled and executed within GMP regulatory guidelines
Working in the lab and working cross-functionally with Process Development (PD) on equipment/process improvements, including, but not limited to, investigating new equipment, identifying raw materials needed for implementation, and training and engineering runs
Assisting with Design of Experiment (DOE), creation of study protocols, data analysis, and completion of final reports to provide data and justification for process optimization and future technology transfers
Supporting Manufacturing group and troubleshooting production activities to ensure safe, quality, and timely manufacture of biopharmaceutical product for pre-clinical, clinical and commercial use
Providing in-person and real-time manufacturing production support (as needed)
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
Collaborating with Supplier Quality and Manufacturing to evaluate change notifications or material non-conformances
Working closely with Quality and Regulatory Affairs departments to ensure compliance with cGMP, ICH and FDA regulations
May include management of deviations and other quality records, performing root cause investigations (6M, 5-Why’s, etc) to determine causal factors and evaluate product impact
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
Qualification
Required
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
Ability to collect and assist in the analyzation/trending of data and information to determine paths for process improvement and potential root cause
Ability to identify process risk and suggest risk mitigation strategies
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, Excel, and PowerPoint 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
Preferred
Bachelor's degree and 2+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry preferred, or equivalent combination of degree/experience
Experience with DOE and writing study protocols and final reports is preferred
Experience with technology transfers into GMP manufacturing preferred
Experience with scale-up of cell therapy processes and closed manufacturing systems preferred
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase