Formulation Scientist

Job DescriptionJob Description

About Capricor Therapeutics

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 skilled Formulation Scientist to join Capricor Therapeutics and drive the development of stable, lyophilized exosome-based formulations for our groundbreaking therapies. In this critical scientific role, you will lead formulation design, optimization, and characterization, ensuring compliance with cGMP and supporting IND-enabling studies. You will collaborate with cross-functional teams, including analytical sciences, process development, and regulatory affairs, to advance our novel exosome-based drug delivery platforms. This role offers a unique opportunity to shape the future of exosome therapeutics, contributing directly to Capricor’s mission to transform the biotech industry and improve lives.

Responsibilities

Strategic Scientific Leadership

• Develop and execute innovative formulation strategies for exosome-based drug products, aligning with Capricor’s mission to deliver transformative therapies for rare diseases, including DMD.
• Stay ahead of advancements in exosome, lipid nanoparticle (LNP), and lyophilization technologies, implementing cutting-edge solutions to maintain a competitive edge.
• Contribute to intellectual property filings and patent strategies, protecting novel formulation technologies and advancing Capricor’s scientific leadership.

Formulation Development

• Design and optimize exosome-based formulations for therapeutic modalities (e.g., nucleic acids, proteins, biologics), ensuring stability at 4&degree;C or room temperature for enhanced shelf-life.
• Lead lyophilization process development for drug substances (DS) and drug products (DP), optimizing excipients, cryoprotectants, and thermal characterization (e.g., DSC, Freeze-Dry Microscopy) to extend stability.
• Develop storage buffers (e.g., LNP-based) to support flexible storage conditions (4&degree;C, room temperature, -20&degree;C) and improve DS/DP integrity.
• Conduct forced degradation, real-time, and accelerated stability studies to ensure formulation robustness under non-frozen conditions.

Analytical & Quality Control

• Perform physicochemical and biophysical characterization using techniques such as DLS, TEM, HPLC, LC-MS, DSC, and fluorescence-based assays to assess formulation performance.
• Develop and validate quality control (QC) methods to evaluate stability, particle size, encapsulation efficiency, and biological activity of exosome-based DS/DP.
• Ensure compliance with cGMP, 21 CFR Part 1271, cGTP, and ICH guidelines, maintaining rigorous quality standards for injectable formulations.

Collaboration & Cross-Functional Support

• Collaborate with analytical scientists, process engineers, and regulatory affairs teams to define critical quality attributes (CQAs) and support IND submissions.
• Partner with process development to transition formulations from R&D to clinical and commercial scale, ensuring scalability and GMP compliance.
• Support technical transfer to contract manufacturing organizations (CMOs), optimizing manufacturing processes for clinical production.

Innovation & Optimization

• Drive advanced formulation optimization to enhance exosome stability and delivery, leveraging data-driven approaches to meet regulatory and clinical demands.
• Monitor and analyze key performance indicators (KPIs) for formulation processes, implementing corrective actions to improve efficiency and reliability.
• Stay current with scientific literature and industry trends, contributing to Capricor’s innovation in exosome-based therapeutics.

Requirements

Minimum Qualifications

• Education: Ph.D. in Pharmaceutical Sciences, Biochemistry, Bioengineering, Chemical Engineering, or a related field with 4+ years of biopharmaceutical industry experience; Master’s degree with 6+ years of relevant industry experience considered.
• Experience: 4+ years of hands-on experience in biologics or vesicle-based formulation (e.g., exosomes, LNPs, liposomes, mAbs, peptides) in the biopharmaceutical industry.
• Lyophilization Expertise: Direct experience with lyophilization process development, including excipient selection, thermal characterization, and cycle optimization for DS/DP stability.
• Stability Optimization: Proven expertise in optimizing formulation stability at 4&degree;C or room temperature through forced degradation, real-time, and accelerated stability studies.
• Analytical Skills: Proficiency in analytical techniques, including HPLC, LC-MS, DLS, TEM, and DSC, for formulation characterization.
• Scientific Leadership: Demonstrated ability to plan and lead initiatives as a hands-on bench scientist in a fast-paced research environment.
• Regulatory Knowledge: Strong understanding of cGMP, ICH guidelines, and compliance with 21 CFR Part 1271 and cGTP for injectable formulations.
• Skills: Exceptional problem-solving, attention to detail, and communication skills, with a collaborative approach to cross-functional teamwork.
• Authorization: Authorization to work in the U.S. without sponsorship.

Skills

• Direct experience with exosome-based therapeutics or vesicle-based systems (e.g., LNPs, liposomes).
• 5+ years of industry experience in biopharmaceutical or regulated environments within GMP or QC settings.
• Expertise in GMP manufacturing, scale-up, and technical transfer to CMOs.
• Experience authoring CMC sections for IND submissions or supporting regulatory interactions.
• Proficiency in data analysis tools (e.g., Microsoft Excel, statistical software) and familiarity with process monitoring techniques.
• Strong scientific communication and technical writing skills for reports, publications, and patent filings.

Location Policy

This position is based in San Diego, CA, with flexibility for occasional remote work as needed.

Work Environment/Physical Demands

• Physical Requirements: Ability to sit and stand for extended periods, lift/carry laboratory equipment and materials up to 40 pounds, move about the lab, and communicate effectively via telephone or in person.
• Flexibility: Willingness to work extended or off hours, including weekends and holidays, as required to meet company needs and ensure research continuity.

Come Work With Us!

Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation, 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 through exosome-based therapeutics, we’d love to hear from you!