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.