616 Formulation Scientist jobs in the United States

Job 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°ree;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°ree;C, room temperature, -20°ree;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°ree;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.

Preferred 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!

• Design and develop innovative drug formulations for various therapeutic areas and dosage forms.
• Conduct pre-formulation studies, including drug solubility, stability, and compatibility assessments.
• Optimize formulations to achieve desired drug release profiles, stability, and manufacturability.
• Perform physicochemical characterization of drug substances and formulated products.
• Develop and validate analytical methods for formulation testing.
• Oversee and execute stability studies according to ICH guidelines.
• Manage technology transfer of formulations from R&D to manufacturing scale.
• Provide scientific expertise and support for regulatory filings (e.g., IND, NDA).
• Collaborate with cross-functional teams, including analytical development, CMC, and clinical research.
• Troubleshoot formulation and manufacturing issues, providing scientific solutions.
• Mentor junior scientists and contribute to team development.
• Stay abreast of current industry trends, new technologies, and regulatory updates in pharmaceutical sciences.

• Design and develop robust pharmaceutical formulations for various dosage forms.
• Conduct pre-formulation studies, including solubility, stability, and compatibility testing.
• Perform formulation characterization and optimize critical process parameters.
• Evaluate drug delivery technologies and identify suitable candidates for pipeline projects.
• Plan and execute laboratory experiments, analyze data, and interpret results.
• Prepare comprehensive formulation development reports and technical documentation.
• Collaborate with analytical teams to develop and validate relevant assays.
• Provide scientific expertise and technical guidance to junior team members.
• Ensure all activities are conducted in compliance with GMP and relevant regulatory guidelines.

• Master's or Ph.D. in Pharmaceutical Sciences, Pharmaceutics, or a related discipline.
• Minimum of 5 years of hands-on experience in pharmaceutical formulation development.
• Proven expertise in at least one dosage form category (e.g., oral solid, injectable, topical, inhalation).
• Strong knowledge of pharmacokinetics, biopharmaceutics, and drug delivery principles.
• Experience with formulation development software and laboratory equipment.
• Familiarity with ICH guidelines and GMP requirements.
• Excellent problem-solving, analytical, and communication skills.
• Ability to work effectively in a multidisciplinary team environment.

• Designing, developing, and optimizing pharmaceutical formulations for various dosage forms (e.g., oral solid dosage, injectables, topical).
• Conducting pre-formulation studies, including solubility, stability, and compatibility testing.
• Utilizing advanced formulation technologies and excipients to improve drug bioavailability and delivery.
• Characterizing drug products using a variety of analytical techniques (e.g., HPLC, dissolution testing, particle size analysis).
• Developing and validating analytical methods for raw materials, in-process samples, and finished products.
• Preparing formulation development reports, protocols, and regulatory submission documents (e.g., IND, NDA).
• Collaborating with process development, analytical development, and manufacturing teams.
• Troubleshooting formulation and manufacturing process issues.
• Mentoring junior scientists and providing technical guidance.
• Staying current with pharmaceutical industry trends, regulatory guidelines, and new technologies.
• Managing external research collaborations and contract manufacturing organizations.
• Contributing to the strategic planning of the formulation development pipeline.

• Design and develop novel pharmaceutical formulations for various dosage forms.
• Conduct pre-formulation studies to characterize drug substances and excipients.
• Optimize formulation composition and manufacturing processes.
• Perform stability studies and assess drug product performance.
• Develop and validate analytical methods for formulation analysis.
• Collaborate with analytical development and manufacturing teams.
• Prepare technical reports, development summaries, and regulatory documentation.
• Ensure compliance with GMP and relevant regulatory guidelines.
• Troubleshoot formulation and manufacturing issues.
• Stay updated on advancements in pharmaceutical formulation and drug delivery technologies.

• Ph.D. or Master's degree in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a related field.
• Minimum of 4 years of experience in pharmaceutical formulation development.
• Strong understanding of drug delivery systems, excipient functionality, and dosage form design.
• Experience with formulation development for oral solid dosage forms, injectables, or other relevant dosage forms.
• Proficiency in laboratory techniques used in pharmaceutical formulation and characterization.
• Knowledge of GMP principles and regulatory requirements for drug development.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills for effective remote collaboration.
• Ability to manage projects independently and meet deadlines.

• Design and develop pharmaceutical formulations for various dosage forms.
• Conduct pre-formulation studies and API characterization.
• Optimize formulation processes for scalability and robustness.
• Perform stability studies and analyze formulation performance.
• Prepare development reports and technical documentation for regulatory submissions (IND, NDA).
• Collaborate with analytical development and quality control teams.
• Investigate and troubleshoot formulation-related issues.
• Stay current with advancements in drug delivery technologies and pharmaceutical sciences.
• Mentor junior scientists and provide technical guidance.
• Ensure all activities comply with cGMP and regulatory guidelines.

• Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
• Minimum of 5-7 years of experience in pharmaceutical formulation development.
• Proven experience with solid dosage forms (tablets, capsules) and/or parenteral formulations.
• Expertise in pre-formulation, solubility enhancement, and drug delivery technologies.
• Proficiency with analytical techniques such as HPLC, UV-Vis, dissolution testing, and DSC.
• Strong understanding of cGMP, ICH guidelines, and regulatory submission requirements.
• Excellent scientific judgment, problem-solving, and critical-thinking skills.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Experience with process development and scale-up is a plus.

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a related field.
• 8+ years of experience in pharmaceutical formulation development, with a focus on innovative dosage forms.
• Extensive knowledge of solid dosage form development, including granulation, tableting, encapsulation, and coating.
• Experience with drug delivery technologies such as controlled release, nanoparticles, or liposomes is highly desirable.
• Proficiency in analytical techniques relevant to formulation characterization (e.g., HPLC, dissolution testing, DSC, TGA).
• Strong understanding of regulatory guidelines (e.g., FDA, EMA) for drug product development.
• Excellent problem-solving, critical thinking, and scientific communication skills.
• Proven ability to lead projects and mentor scientific staff.
• Experience working in a remote or hybrid research environment is a plus.

• Lead the formulation development of new pharmaceutical products, focusing on oral solid dosage forms, parenteral solutions, or other advanced delivery systems.
• Design and execute experimental studies to evaluate excipient compatibility, drug solubility, and formulation stability.
• Develop and optimize drug formulations to achieve desired pharmacokinetic profiles and therapeutic effects.
• Conduct pre-formulation studies, including physical characterization, solid-state analysis, and polymorphism screening.
• Utilize advanced analytical techniques (e.g., HPLC, GC, MS, DSC, TGA, XRPD) for characterization and quality control.
• Scale-up formulations from laboratory bench to pilot plant and manufacturing scale, ensuring process robustness and reproducibility.
• Prepare comprehensive development reports, regulatory submission documents (e.g., IND, NDA sections), and scientific publications.
• Collaborate with analytical development, manufacturing, regulatory affairs, and clinical teams to ensure project success.
• Stay abreast of the latest scientific literature, industry trends, and regulatory guidelines in pharmaceutical formulation and drug delivery.
• Troubleshoot formulation and process-related issues, providing effective solutions.
• Manage multiple projects simultaneously, ensuring timely completion of milestones.
• Mentor junior scientists and provide technical leadership within the formulation development group.
• Evaluate and implement new formulation technologies and techniques.
• Conduct stability studies according to ICH guidelines and analyze the resulting data.
• Ensure all development activities comply with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Contribute to intellectual property generation through patent applications.

• Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
• Minimum of 7 years of experience in pharmaceutical formulation development, with a strong focus on solid dosage forms or parenteral products.
• Extensive experience with various dosage forms and drug delivery technologies.
• In-depth knowledge of physical pharmacy principles, excipients, and drug-excipient interactions.
• Proficiency in analytical techniques commonly used in pharmaceutical characterization.
• Demonstrated experience in scaling up pharmaceutical processes.
• Familiarity with regulatory requirements for drug development (FDA, EMA, ICH).
• Strong understanding of GMP and GLP environments.
• Excellent problem-solving, critical thinking, and data analysis skills.
• Effective communication, interpersonal, and project management skills.
• Ability to work independently and collaboratively in a multidisciplinary team.
• Experience with biologics formulation is a plus.
• Publication record or relevant patents are advantageous.