Scope of Function:
Assists in all Upstream Manufacturing activities including;
- Responsible for the preparation, sterilization and dispensing of cell culture and fermentation utensils, including documentation and other duties involved in the operation of process development laboratories.
- Compiles electronic /laboratory notebooks, maintains laboratory equipment, and equipment logs and monitors supplies.
- General knowledge of laboratory procedures especially aseptic technique is required.
Reports To: Upstream Manufacturing Manager
- Maintains laboratory inventory and equipment.
- Cleans and prepares glassware and utensils as needed.
- Assists with cell culture operations utensils readiness activities
- Maintains accurate and current records per GBI specifications.
- Maintains the GMP Manufacturing area per GBI specifications.
- Adheres to all GBI policies and safety guidelines.
- Operation of GMP Steam Sterilization System (Autoclave).
- Preparation and sterilization of Vessels and Utensils to support Manufacturing
- Verification of facilities Utilities Systems.
- Critical Cleaning of all GMP Manufacturing suites.
- Assisting Facilities Department on all daily responsibilities.
- Familiarity with Good Manufacturing practices preferred and good mechanical aptitude required.
A High School diploma and experience in GMP Pharmaceutical/biotech environment is preferred.
Must have strong organizational skills and experience using Microsoft Office
Education & Experience:
- High School graduate or AS in biological or physical science.
(Degree requirement may be waived with relevant experience).
- 0-1 years GMP manufacturing experience required
Downstream Manufacturing,, Quality Control, Quality Assurance, Materials