The Role
The MSAT Training Specialist II/III develops and delivers GMP training programs, mentors staff, maintains regulatory documentation, and ensures compliance in cell therapy manufacturing.
Summary Generated by Built In
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 an MSAT Training Specialist II/III at Capricor, you will play a pivotal role in ensuring operational excellence and GMP compliance across our cell therapy manufacturing processes. This position focuses on designing and delivering robust training programs, mentoring manufacturing personnel, and maintaining documentation that supports regulatory readiness and high-quality production. Ideal candidates thrive in a dynamic biotech environment, combining technical expertise with a commitment to continuous improvement and team development.
Responsibilities
- Develop and deliver training sessions on GMP cell culture manufacturing, cell counting, and aseptic techniques.
- Design and implement innovative training modules and programs to enhance engagement and retention.
- Collaborate with subject matter experts to align training materials with regulatory standards.
- Mentor and coach manufacturing personnel, fostering a culture of continuous growth and strict GMP adherence.
- Oversee the creation, review, and maintenance of SOPs, batch records, and technical documents for training and compliance.
- Lead investigations, interviews, root cause analyses, and impact assessments for deviations, CAPAs, and change controls.
- Manage the training lab, ensuring it is fully equipped, stocked, and prepared for all training activities.
- Partner with Quality Assurance, Manufacturing, and Regulatory Affairs to integrate training with operational and compliance workflows.
- Monitor and evaluate training effectiveness using feedback, performance metrics, and audits to drive continuous improvement.
- Stay current with industry trends, regulatory changes, and best practices.
Requirements
- Bachelor’s degree in a life science discipline (e.g., Biology, Biotechnology) or equivalent experience.
- 3-7 years of experience with mammalian cell culture manufacturing in a GMP environment.
- Proven expertise as a Subject Matter Expert or Trainer in GMP cell culture manufacturing.
- Extensive experience authoring and reviewing SOPs, batch records, and technical documents.
- Advanced knowledge of aseptic techniques, cell counting, and GMP production methods.
- Communication and presentation skills for diverse audiences.
- Exceptional communication skills and attention to detail for training materials and records.
- Ability to work independently and in a team in a dynamic setting.
- Experience with cleanroom operations and gowning procedures preferred.
- Knowledge of cell therapy manufacturing processes preferred.
Work Environment & Physical Demands
- Primarily laboratory-based with required time in GMP cleanroom environments addressing training and documentation.
- Requires prolonged periods of standing, computer use for training materials, and gowning for cleanroom work.
- May involve lifting materials or equipment up to 20 pounds.
- Ability to navigate laboratory and GMP environments for training and oversight.
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.
Skills Required
- Bachelor's degree in a life science discipline or equivalent experience
- 3-7 years of experience with mammalian cell culture manufacturing in a GMP environment
- Proven expertise as a Subject Matter Expert or Trainer in GMP cell culture manufacturing
- Extensive experience authoring and reviewing SOPs, batch records, and technical documents
- Advanced knowledge of aseptic techniques, cell counting, and GMP production methods
- Communication and presentation skills for diverse audiences
- Exceptional communication skills and attention to detail for training materials and records
- Ability to work independently and in a team in a dynamic setting
- Experience with cleanroom operations and gowning procedures preferred
- Knowledge of cell therapy manufacturing processes preferred
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The Company
What We Do
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of cell and exosome-based therapeutics. Its lead product candidate, Deramiocel, is an allogeneic cell therapy currently in late-stage clinical development for the treatment of Duchenne muscular dystrophy (DMD). The company also leverages its proprietary StealthX™ exosome platform for the targeted delivery of therapeutic agents to treat a wide range of diseases.
