MSAT Associate 2 (Tech Transfer and Process Optimization)

Capricor Therapeutics•San Diego, CA

About The Position

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 StealthXâ¢ 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. Capricor is seeking a tenacious, science-oriented individual with a proficient knowledge of GMP manufacturing and an understanding of cell culture/cell therapies. The MSAT Associate I/II will need to learn/train quickly to provide Subject Matter Expert (SME) feedback for the various manufacturing processes. This position will support CMC operations focusing on all areas, including, but not limited to, process development/optimization, technology transfers, change controls, Deviation management, root cause investigations, manufacturing operations, and creation/revision of controlled documents.

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.
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).
Experience with technology transfers into GMP manufacturing preferred.
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.

Nice To Haves

Additional experience with cells in suspension is a plus.
Experience with DOE and writing study protocols and final reports is preferred.
Experience with scale-up of cell therapy processes and closed manufacturing systems preferred.

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.