MANUFACTURING ASSOCIATE I/II

Capricor Therapeutics | Manufacturing Associate I/II

Capricor Therapeutics is a biotechnology company dedicated to transforming the lives of patients through pioneering therapies for severe and complex diseases. With a mission centered on advancing cell and exosome-based technologies, we’re focused on high-impact solutions for unmet medical needs, including Duchenne muscular dystrophy. Our work redefines what’s possible in healthcare by leveraging cutting-edge science with an unwavering dedication to patient outcomes. Join our passionate team where innovative science meets patient-centered care.

Position Overview: Manufacturing Associate I/II

As a Manufacturing Associate, you’ll be a vital part of Capricor’s efforts in delivering therapies for patients in need. Supporting critical clinical trials and exosome development, you’ll perform meticulous production tasks and documentation to uphold our quality and compliance standards. This role places you in a cleanroom environment, where precision and attention to GMP standards are essential. You’ll be instrumental in ensuring that each production step is performed with accuracy, ultimately contributing to Capricor’s therapeutic success.

Responsibilities:

• Perform routine manufacturing tasks, including media preparation, cell culture, cell counting, formulation, centrifugation, and freezing.
• Complete and ensure timely, accurate documentation in compliance with GMP standards across batch records, forms, and protocols.
• Mentor fellow team members on cGMP documentation protocols to ensure the highest standards.
• Plan, collect, analyze, and report on production data, maintaining comprehensive records and observations.
• Author, revise, and maintain SOPs through Capricor’s document change system.
• Oversee inventory, material transfers, and cleanroom procedures to support efficient GMP operations.
• Prepare technical summaries, protocols, and reports to ensure full documentation of production activities.
• Lead moderate-complexity CAPAs and assist with deviations and investigations to maintain quality assurance.
• Take on special projects in manufacturing and development as required.

Requirements:

• Bachelor’s degree in Biomedical Engineering, Biological Sciences, or a related field.
• 1-3 years of experience in a cGMP/cGTP manufacturing environment.
• Solid laboratory experience in mammalian tissue culture, along with expertise in aseptic techniques.
• Working knowledge of regulatory standards in biopharmaceutical or tissue banking industries.
• Strong organizational skills and acute attention to detail within a fast-paced, dynamic setting.
• Basic molecular biology and flow cytometry skills are a plus.
• Adaptability to work schedules that may include weekends or holidays as needed.

Work Environment and Physical Demands:

• Comfortable working in a controlled cleanroom and biosafety cabinet (BSC) environment, including wearing full protective gear (e.g., “bunny suit”) to maintain stringent sterile conditions.
• Ability to sit and stand for extended periods.
• Capable of lifting and carrying materials up to 40 pounds, navigating the facility, and communicating efficiently in person and over the phone.
• Comfortable working in a cleanroom environment, including full gowning as required.
• Flexibility to work extended or off-hours to meet production schedules, including weekends and holidays.

Why Capricor?

Capricor Therapeutics is an industry leader in cell and exosome therapy, pushing boundaries to create groundbreaking treatments that elevate standards of care. Driven by science and grounded in integrity, our team is dedicated to meaningful impact through patient-centered innovation. Be part of a team that’s changing lives—join Capricor and help us shape the future of healthcare.