Manufacturing Lead, Roseville

Summary:    

Ensure daily material planning and manufacturing activities for RBX2660 and other Rebiotix clinical and development drug products are completed.

Responsibilities:

• 
  
• Follow cGMP requirements- ensure all manufacturing activities are performed following written procedures and report infractions to Manager
  
• Prepare production and daily/weekly personnel work schedules in coordination with the Manager
  
• Plan cleaning, manufacturing, and documentation activities in a manner that maximizes efficiency
  
• Ensure released inventory remains at target quality and inventory levels
  
• Lead, direct and participate in manufacturing operations including donation/DHS collection, drug substance manufacturing, and cleaning activities
  
• Ensure production areas are kept in a neat and orderly state
  
• Communicate daily production activities and performance against targets to the Manufacturing Manager
  
• Monitor production activities for issues or concerns, communicate issues or concerns promptly to the Manufacturing Manager
  
• Create or modify technical documents to meet new or revised requirements
  
• Generate monthly performance metrics for the manufacturing area
  

Requirements:

• 
  
• 3+ years GMP Pharmaceutical experience
  
• Experience with manufacturing processes
  
• Capsule Manufacturing experience preferred
  
• cGMP manufacturing experience
  
• Experience in a controlled, regulated work environment
  
• Must have excellent communications skills
  
• Experience with technical documents and technical reports
  
• Must be detailed oriented and able to follow specific work instructions
  
• Must be able to accurately perform calculations per batch records
  

We are proud to be an Affirmative Action/EEO Employer.  EOE Minorities/Females/Protected Veterans/Disabled

We maintain a drug-free workplace and perform pre-employment substance abuse testing.