Senior GMP peptide production chemist
The peptide Chemist role is to develop the generic/non generic peptide portfolio. This involves developing optimised peptide manufacturing processes, manufacturing under cGMP conditions and to perform related activities.
Carry out peptide manufacture by solid phase peptide chemistry and solution phase chemistry.
These activities will range from development through to batch manufacture to cGMP, from mg to multi Kilo scale.
The role will include Perform purification process by chromatography, crystallization and other techniques, and in-process test method
Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP materials, perform in-process test, package the product including other related activities
Perform project-planning and initiate raw material order-request. Receive raw materials, coordinate with QA/QC and Material Management for material release and monitor raw material inventories
Install, test equipment, operate and maintain equipment for manufacturing and in-process testing.
The equipment includes analytical HPLC and prep HPLC system, Lyophilises, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and others used in manufacture
Develop processes for purification of chemicals other than peptides
Follow and maintain GMP Documentation System. Investigate any process deviation and write process deviation report. Initiate document change request. Help quality control and assurance unit to maintain equipment calibration program
Routinely maintain/organize work areas (Hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facility
Develop peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methods
Assist QA/QC for monitoring raw material inventories
Write Standard Operation Procedures, Standard Test Procedures, Master Batch Records and other related GMP documents
Follow SOPs and approved directions to clean equipment used in GMP processes, maintain cleaning log for each equipment, assist in equipment calibration program, and dispose chemical waste generated in the manufacture
Monitor compliance of Maintenance and Cleaning procedures of equipment and instruments used in GMP processes by periodically reviewing and signing off on maintenance and cleaning log for each equipment
Skills and Experience
Significant experience in GMP Peptide Manufacturing
Experience in synthesis or purification of GMP peptides
Relevant educational background
You must be eligible to work in the UK. Learn more
- Agency: SRG
- Reference: J36606
- Updated: 30th June 2020
- Expires: 27th July 2020