Quality Control Manager

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our innovative platforms, including our lead product, deramiocel (CAP-1002), and our proprietary StealthX™ platform, to engineer cutting-edge treatments. Our team is committed to harnessing advanced science and technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a

About the Role

We are seeking a Manager of Quality Control to join our Quality Control team in San Diego, CA. In this role, you will oversee daily operations of the QC team, support analytical testing of current products, and help define strategies for new product development. You will collaborate with the Analytical Development team to create and implement new assays and analytical methods, ensuring their successful transfer into QC. Products may include cells, exosomes, and other regenerative therapeutics. This role is ideal for a motivated professional who thrives in a collaborative environment and is capable of working independently to drive continuous improvement and innovation in quality control.

Responsibilities:

• Lead and manage the Quality Control team in the development, implementation, and maintenance of the Quality Management System (QMS), ensuring compliance with FDA regulations (21 CFR Parts 210 & 211), ICH guidelines, USP standards, and relevant quality system requirements.
• Oversee the testing and analysis of in-process intermediates, final formulated bulk drug substances, and final drug products to ensure timely and compliant material release.
• Manage daily QC operations, including personnel, sample management, data analysis, investigation of out-of-specification (OOS) results, and monitoring of stability data.
• Direct the stability program, including managing protocols, timelines, data review, and ensuring accurate reporting.
• Collaborate closely with the Analytical Development team to facilitate the successful transfer of analytical methods into the QC laboratory.
• Oversee and participate in design of qualification and validation for analytical methods.
• Interface with and manage third-party contract laboratories to ensure that results are delivered on time and meet required quality standards.
• Lead the creation, revision, and review of SOPs, test methods, qualification/validation protocols, and associated reports.
• Prepare data packages and regulatory dossiers for interactions with health authorities and support regulatory agency communications.
• Provide leadership and guidance to ensure QC analysts are properly trained and capable of executing all necessary quality functions.
• Compile and present key performance indicators (KPIs) for QC activities to senior management.
• Perform additional duties as required to support the team and company’s objectives.

Requirements:

• 7 years of experience working in a GMP Quality Control laboratory or a combination of experience in a GMP/GLP setting is required.
• At least 2 years in a leadership role within the biopharmaceutical or cell therapy industry.
• In-depth knowledge of FDA regulations, ICH guidelines, USP standards, and cGMP requirements for cell therapy or biologics.
• Bachelor’s degree in a relevant Biological Science discipline is required. Master’s degree preferred.

• Familiarity with laboratory methods including flow cytometry, Real-Time PCR, DNA isolation, ELISA, bioactivity assays, endotoxin detection etc. is required
• Experience with method qualification/validation is required
• The ability to independently perform laboratory analysis, troubleshoot, and improve methods is required
• A history of successful, independent laboratory work should be demonstrated
• Excellent communication skills and the ability to work as part of a team are required

Work Environment / Physical Demands:

• Must be able to sit and stand for extended periods.
• Must be able to lift / carry reports and materials up to 40 pounds, move about the office.

Compensation (USD): $120,000 - $135,000

• This role offers a competitive salary based on experience and qualifications. Additional benefits include health/dental/vision insurance, paid time off, parental leave, 401k retirement plan, company stock options, and bonus eligibility.

Location Policy:

This position is based at our headquarters in San Diego, California, with flexibility for occasional remote work as needed.

Come Work With Us!

Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation and benefits, generous vacation and parental leave, flexible working hours, and a collaborative work environment. If you are excited about joining a team that’s transforming the biotech industry and making a real impact on patients’ lives, we’d love to hear from you!