Senior GMP Peptide Chemist

Senior GMP Peptide Chemist
  • Competitive
  • Permanent
  • Leicester, Leicestershire, England, UK LE19 4SD Leicester Leicestershire UK LE19 4SD
Job Ref: J36606
Sector: Science
Sub-sector: Pharmaceuticals
Date Added: 29 June 2020
Senior GMP Peptide Chemist

Senior GMP peptide production chemistYour ResponsibilitiesThe 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.The RoleCarry 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 methodFollow 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 activitiesPerform 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 inventoriesInstall, 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 manufactureDevelop processes for purification of chemicals other than peptidesFollow 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 programRoutinely maintain/organize work areas (Hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facilityDevelop peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methodsAssist QA/QC for monitoring raw material inventoriesWrite Standard Operation Procedures, Standard Test Procedures, Master Batch Records and other related GMP documentsFollow 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 manufactureMonitor 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 ExperienceSignificant experience in GMP Peptide ManufacturingExperience in synthesis or purification of GMP peptidesRelevant educational background

29/07/2020 15:52:18
Contact Consultant:
James Windridge

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