Formulation Scientist

Capricor Therapeutics 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 proprietary StealthX™ platform to engineer innovative treatments. Our team is committed to harnessing cutting-edge science and advanced 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 healthier future.

About the Role

We are seeking a highly motivated and skilled Formulation Scientist to join our Exosome Research team. The successful candidate will lead efforts in designing, optimizing, and characterizing exosome-based drug formulations for therapeutic applications. This role will involve close collaboration with cross-functional teams in process development, analytical sciences, and clinical research to advance our novel drug delivery platforms.

Key Responsibilities

Formulation Development & Stability

• Design and optimize exosome-based drug delivery systems for various therapeutic modalities, including nucleic acids, proteins, small molecules, and biologics.
• Develop lyophilization processes to enhance formulation stability and extend shelf life.
• Select and optimize excipients for cryoprotection and formulation stability.

Process Development & Scale-Up

• Collaborate with cross-functional teams to transition formulations from R&D to clinical and commercial scale.
• Optimize manufacturing processes and ensure scalability for GMP production.

Characterization & Analytical Method Development

• Conduct physicochemical and biophysical characterization of formulations using DLS, TEM, HPLC, LC-MS, DSC, and fluorescence-based assays.
• Establish and validate analytical methods for assessing particle size, encapsulation efficiency, and formulation stability.
• Design and execute stability studies for long-term formulation performance.

Regulatory & Compliance Support

• Support regulatory submissions by preparing technical reports, data summaries, and responding to agency queries.
• Ensure compliance with ICH guidelines and regulatory requirements for injectable formulations.

Collaboration & Innovation

• Work closely with interdisciplinary teams, including analytical scientists, process engineers, and clinical researchers, to drive formulation advancements.
• Stay up-to-date with scientific advancements in exosome, lipid nanoparticle (LNP), and lyophilization technologies.
• Contribute to intellectual property filings and patent strategies.

Requirements

Minimum Qualifications:

• Ph.D. with 3 years or Master’s with 5 years of industry experience in exosome-based drug formulation, lipid nanoparticle (LNP) formulation, lyophilization, or related drug delivery systems.
• Expertise in formulation development and optimization for nanoparticle-based drug delivery systems.
• Strong background in lyophilization process development, excipient selection, and formulation stability optimization.
• Proficiency in analytical techniques including DLS, TEM, HPLC, UV-Vis, and LC-MS.
• Experience in GMP manufacturing, scale-up, and tech transfer is a plus.
• Strong problem-solving skills, attention to detail, and ability to work in a fast-paced research environment.

Preferred Qualifications:

• Understanding of regulatory requirements for injectable formulations, including ICH guidelines.
• Experience working in a biotech or pharmaceutical industry setting focused on advanced drug delivery technologies.
• Strong scientific communication and technical writing skills.

Compensation (USD)

Salary Range: $110,000 - $125,000 (commensurate with experience and qualifications).
 Additional benefits include health insurance, retirement plans, stock options, and professional development opportunities.

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 offers competitive compensation and benefits, generous vacation and parental leave, flexible working hours, and a collaborative work environment.
 If you’re excited about advancing cutting-edge therapies in the biotech industry, we’d love to hear from you!

Salary : $110,000 - $125,000