Manufacturing Associate I

SupportFinity™; San Diego (CA); On-site; USD 50,000 - 70,000; Full time

Job summary

A biotechnology company in California, San Diego is seeking a Manufacturing Associate I to support clinical trials and exosome development. You will perform essential manufacturing tasks in a cleanroom environment, ensuring compliance with GMP standards. The ideal candidate has a Bachelor’s degree in Biomedical Engineering or Biological Sciences and 1-3 years of relevant experience. Join an innovative team dedicated to advancing transformative therapies for rare diseases, driving scientific excellence and patient-centered impact.

Qualifications

• 1-3 years of experience in a cGMP/cGTP manufacturing environment.
• Adaptability to work schedules that may include weekends or holidays.

Responsibilities

• Perform routine manufacturing tasks, including media preparation and cell culture.
• Complete and ensure timely, accurate documentation in compliance with GMP standards.
• Mentor team members on cGMP documentation protocols.
• Plan, collect, analyze, and report on production data.
• Author, revise, and maintain SOPs.
• Oversee inventory and cleanroom procedures for efficient GMP operations.

Skills

Mammalian tissue culture

Aseptic techniques

Regulatory standards knowledge

Organizational skills

Attention to detail

Education

Bachelor’s degree in Biomedical Engineering or Biological Sciences

Job description

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.

As a Manufacturing Associate I, 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

Qualifications

• 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

Why Capricor?

Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!

At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies

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