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- San Diego, California, United States
- San Diego, California, United States
Über
Capricor Therapeutics 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.
Responsibilities- Maintain facilities and process equipment supporting Commercial and Clinical manufacturing, Research and Development, and related services.
- Manage staff to support 24/7 operations, ensuring safe, reliable, and cost-effective usage.
- Coach, guide, and direct the facility team, monitoring and assessing performance of maintenance personnel and contractors.
- Leverage prior GMP knowledge and experience to present to FDA or other regulatory agencies.
- Collaborate with teams to identify and implement continuous improvement opportunities for systems and processes.
- Specify and recommend equipment modifications to enhance safety, reliability, and operability.
- Communicate regularly with customers, partners, and stakeholders to share key developments, opportunities, and risks.
- Manage operating status and outages for systems, facilities, and utilities to maximize uptime.
- Develop and implement corrective action plans for facility system repairs, replacements, and modifications.
- Ensure timely completion of maintenance work orders.
- Track facilities expenditures and prepare the annual budget.
- Foster a culture of inclusion, prioritizing safety and injury prevention.
- Maintain compliance by updating maintenance and operations SOPs for improved scheduling and equipment uptime.
- Perform additional assigned duties as needed.
- High School Diploma/GED or local equivalent required; Bachelor's degree in a relevant field preferred.
- 5-8 years of relevant maintenance experience required.
- 2-4 years of managerial experience in pharmaceuticals, biotech, food processing, high-tech, or other heavily regulated industries required.
- 2+ years of experience managing facilities under GMP regulatory compliance required.
- Comprehensive knowledge of maintenance practices for equipment such as boilers, chillers, air handlers, HVAC systems, cooling towers, pure steam generators, Water for Injection systems, autoclaves, heat exchangers, security systems, electrical distribution, fire protection, clean-in-place systems, classified air systems, RODI systems, emergency generators, and fume exhaust systems.
- Familiarity with pharmaceutical manufacturing equipment, including liquid filling machines, stoppering machines, capping machines, vial washers, and dehydrogenation ovens.
- Ability to manage multiple responsibilities with strong self-motivation.
- Capability to work independently and collaboratively in a team-oriented environment.
- Trained in cGMP operations for pharmaceutical, biotechnology, or medical device manufacturing.
- Knowledge of aseptic gowning and cleaning techniques.
- Proficiency in managing after-hours responses and extended shifts to support planned or unplanned events.
- Strong analytical, problem-solving, and communication skills.
- Leadership skills to guide and coach teams effectively.
Work Environment / Physical Demands:
- Primarily facility-based, involving oversight of manufacturing and R&D systems, with tasks including maintenance, inspections, and documentation.
- Requires accessing small spaces to assess mechanical issues and standing or walking for extended periods.
- Involves prolonged periods of computer use for tracking expenditures, preparing budgets, and updating SOPs.
- May require lifting up to 50 pounds.
- May involve after-hours responses and extended shifts to support facility operations.
- Occasional travel may be required for regulatory presentations or vendor interactions.
$120,000 - $140,000 a year
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.
Sprachkenntnisse
- English
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