Description

HBT Labs develops and commercializes complex injectable generic and 505(b)(2) pharmaceutical products leveraging its technical expertise and capital resources. Formed in 2013, the Company launched its first commercial product in the US in 2020 and will launch its next two products in the US in the next three years, while developing several new pipeline products. HBT Labs maintains two facilities in Brea, California for both R&D and GMP manufacturing. 

Job Purpose/Summary

The manufacturing technician will support all aspects of the manufacturing operations at HBT Labs. This includes cleaning equipment and cleanrooms, visual inspections, working with product development, packaging clinical supplies, investigations, preparation of batch records and compliance with quality systems, prepare equipment and cleanroom for production and work collaboratively with all other departments.

Duties and Responsibilities

• Perform manufacturing and development activities within a cleanroom environment
• Clean and maintain equipment, cleanroom and facilities
• Collaborate with other departments to prepare developmental drugs
• Perform visual inspections
• Prepare process equipment skid setup for manufacturing processes
• Exercise critical thinking in connection with investigations and troubleshooting experiments and process development
• Review and approve batch records and logbooks
• Comply with and ensure all staff comply with all safety policies and procedures

Requirements

Knowledge, Skills and Abilities

• Knowledge of cGMP preferred
• Skills working in controlled environment are critical; knowledge of product and process development, manufacturing equipment, processing/testing laboratory techniques, and regulatory requirements extremely helpful
• Flexibility to adapt to changing priorities, and ability to manage multi-task and handle multiple projects required
• Excellent written and oral communication skills

Experience

• One or more years of pharmaceutical manufacturing experience preferred

Education and Certifications Required

• Associates Degree or other pharmaceutical certifications are a plus

Work Environment

• GMP and GLP knowledge consistently applied
• Manufacturing cleanroom environment wearing PPE
• Walking 20-80%
• Prolonged standing up to 40%
• Occasional lifting up to 50 lbs