Website Goodwin Biotechnology
Scope of Function:
Responsible for cGMP Filling Operations; including preparation and execution of manual filling operations, and validation runs according to the GMP guidelines. Responsible for the cleaning and sterilization of items for Upstream, Downstream, and Fill Finish and Support manufacturing teams, Upstream and Downstream Process Development, Facilities and QC Microbiology team. Responsible for the preparation of buffers for Downstream and Upstream manufacturing teams Responsible for the preparation of media for Upstream Manufacturing Team.
Reports to: Manager, Fill Finish MFG. Support
- Cleaning of materials and equipment for use in Manufacturing, and Quality Control
- Preparation of cleaning solutions.
- Cleaning and verification (Leak Test and Bowie-Dick Test) of the autoclaves.
- Sterilization of materials and equipment for the following departments:
- QC (Microbiology), Process Development Labs (Upstream and Downstream), Manufacturing (Upstream, Downstream, Fill Finish & Support), and Facilities (Cleaning Crew).
- Perform aseptic filling operations, including but not limited to: preparation, filling, stoppering, crimping.
- Assist Manufacturing as directed by Supervisor, including but not limited to: media and buffer preparation.
- Creation and revision of standard operating procedures (SOP) and manufacturing item specifications (CP, RM, GS) as directed by Supervisor.
Minimum of High School Diploma. Associate Degree in Science or higher education is preferred.
A minimum of 1 year experience in cGMP manufacturing is preferred.
QA, QC, FAC, MM, USP, DSP, PD, CS, Vendors as required.