Position: Manufacturing Supervisor 

Capricor seeks an independent, tenacious, science-oriented individual with manufacturing management experience and strong coaching skills. This individual will be supporting technology transfer to establish a commercial-scale process and to assist the manufacturing team to support cGMP clinical manufacturing for clinical trials.

Responsibilities: 

• Train, develop and coach manufacturing staff to ensure proper and effective training, quality standards and standards of performance are met within the manufacturing group
• Supervise the on-the-floor operations of manufacturing facility in a cGMP environment, including but not limited to participating in the manufacturing process as needed
• Reviews batch records for accuracy and reports deviations to Quality Assurance 
• Accountable for accurate SOPs and records (implement as needed, revise and maintain) 
• Create and manage production and resource schedule against operational plan
• Coordinate with Quality to support PM schedules to ensure all equipment is calibrated and maintained as required
• Support all manufacturing deviations, investigations, corrective and preventive actions and change controls (author or review as needed)
• Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
• Coordinate with outside vendors and stakeholders to minimize manufacturing interruptions 
• Identify and own process improvement opportunities and support incorporation of new manufacturing processes
• Identify, escalate and facilitate the resolution of manufacturing, supply chain, analytical and quality issues that may adversely affect production goals
• Maintain strong collaborative relationships with company’s Quality Assurance and Control units and work closely with Quality department to ensure compliance with cGMP, ICH and FDA regulations
• Serve as a liaison between manufacturing and leadership teams and support Manufacturing Management as needed
• Perform such other duties as may be assigned to you from time to time

Requirements:

• Bachelor’s degree required (Master’s preferred) 
• 5 years of hands-on cGMP manufacturing experience in pharmaceutical or biotech industry and cGMP cell manufacturing experience
• Strong leadership ability
• Exceptional communication and interpersonal skills
• Ability to work in a dynamic environment, multi-task, and prioritize work
• Demonstrated critical thinking and problem-solving skills
• Must have full working knowledge of cGMP regulations 
• Must have a strong scientific background with deep knowledge of biologics and cell therapy and Molecular biology experience a plus.
• Adaptable/flexible with work schedule with an ability to multi-task and prioritize work 
• From time-to-time extended hours may be required with or without notice, dependent on the work needed