Summary: This function is to develop peptide manufacture process, manufacture GMP material and perform related activities at Bachem.
• BS degree in Chemistry or related disciplines
• 1-3 years’ work experience
• Experience with HPLC and chromatography
• May work with hazardous materials and chemicals
• Exhibit detail oriented documentation skills
• Ability to follow directions
• Ability to effectively organize, multitasks, and works in a fast-paced, deadline driven work environment.
• Excellent written and oral communications skills
• Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues.
• Ability to work independently and manage one's time
• Basic computer knowledge, including Microsoft word and excel (used daily)
• Communicate effectively and ability to function well in a team environment
• Environment requires that gowning in the form of bunny suits, gloves, hair net, no makeup or jewelry can be worn when working in the clean room environment.
• Experience with Peptides
• General lab instrument ( MS UV Spectrometry) knowledge and operation experience
• Knowledge of cGMP and FDA regulations a plus
This position requires the employee to regularly stand, walk, sit and talk or hear for 5 to 6 hours. The employee must also be capable of writing, using a computer keyboard, telephone and related office equipment as well as lab related equipment. The ability to lift up to 50 lbs. is also required.
The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Within the facility, the employee will experience normal office conditions with a well- lighted work area and minor noise from standard office equipment. Occasionally the employee will experience unpleasant odors from the manufacturing facility. On a daily basis, the employee will visit the manufacturing facility several times. Lab coat and goggles will be required for these visits. The employee will constantly experience laboratory hazards. Very occasionally, the employee will be called upon to address emergency situations.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
• Perform synthesis process including solution phase and solid phase peptide synthesis, peptide resin cleavage, resin cleavage with HF or other chemical cocktails
• 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, lyophilizers, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and others used in manufacture
• Follow SOPs and approved directions to clean equipment, glassware used in GMP processes and maintain cleaning logs for each equipment
• 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
• Dispose chemical waste generated in the manufacture
• 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
• Develop processes for purification of chemicals other than peptides
• Assist QA/QC for monitoring raw material inventories
• Write Standard Operation Procedures, Standard Test Procedures, Master Batch Records and other related GMP documents
• Follow approved GMP manufacture directions such as Master Batch Records, Standard Operation Procedures, Standard Test Procedures and other procedures to manufacture GMP material, perform in-process test, package the product and other related activities
• Install, test equipment, operate and maintain equipment for manufacturing and in-process testing. The equipment includes analytical and prep HPLC systems, lyophilizers, balances, reactors, diafiltration systems, water purification systems, ovens, washing systems, and others used in manufacture
• 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
• Follow and maintain GMP Documentation System. Investigate any process deviation, write process deviation report, and initiate document change request
• Safety Training
• GMP regulatory training
STANDARDS OF CONDUCT
• Maintain professional relationships with supervisors, employees, suppliers and appropriate others.
• Ethical representation of the company in all activities