Production Chemist II
- Employer
- Bachem
- Location
- Torrance, CA, US
- Start date
- Sep 16, 2020
View more
- Discipline
- Manufacturing & Production, Supply Chain, Science/R&D
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach
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Your Responsibilities
The Chemist II (Chem. II) function is to work in a cGMP-regulated environment manufacturing active
pharmaceutical products (APIs) as well as performing related activities at Bachem.
Your Tasks
Install, operate and maintain equipment for manufacturing and in-process testing. The equipment includes but not limited to analytical HPLC/UPLC, prep. HPLC systems, lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, ovens, washing systems and others used in manufacture
Perform solid phase and liquid phase synthesis, deprotect and cleave the API from the resin using chemical cocktails, containing HF, TFA, ammonium hydroxide or other chemicals
Perform purification process by chromatography, crystallization and other techniques
Follow approved GMP manufacture directions such as Master Batch Production Records (MBPRs), Standard Operation Procedures (SOPs), Standard Test Procedures (STMs) and other procedures to manufacture GMP materials, perform in-process test, package intermediate as well as final products and 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
Follow and maintain GMP Documentation System. Initiate, investigate and closure of deviations, CAPAs, investigations, reports and related documents
Routinely maintain/organize work areas (Hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facility
Help write and suggest improvements for Standard Operation Procedures (SOPs), Standard Test Procedures (STMs), Master Batch Records (MBPRs) and other related GMP documents
Follow SOPs and approved directions to clean equipment, glassware used in GMP processes and maintain cleaning logs for each equipment. Dispose of 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
Takeover housekeeping ownership of production equipment and rooms
Help quality control and assurance unit to maintain equipment calibration, qualification and maintenance program
Assist in the development of peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methods
Assist in the development processes for synthesis and purification of chemicals other than APIs
Train other operators on SOPs, equipment and operations required on the shop floor
Ensure all equipment being used for the project is adequately labeled with the status of the equipment
Your Profile
Minimum of 3 years' work experience
Bachelor's Degree in Chemistry or related field
Experienced in cGMP manufacturing
Maintaining good housekeeping
Excellent written and oral communication skills
Communicate effectively and ability to function well in a team environment
Ability to communicate in a proactive and solution-focused manner, including keeping direct supervisor aware of potential issues
Flexibility of working hours based on business needs, may include some nights and occasional weekends
Ability to work independently and manage one's time
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Detail oriented with the ability to troubleshoot and resolve problems
Good computer knowledge, including Microsoft Word, Excel and PowerPoint
Experienced using analytical HPLC/UPLC, prep HPLC system, lyophilizers, balances, solid as well as liquid phase reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and other equipment used in manufacturing
Experienced in working in a clean room environment (ISO 7 & ISO 8 classified rooms)
Capable of qualifying equipment and performing routine maintenance on equipment
Capable of training other operators
Work with hazardous materials and chemicals
Preferred:
Experience in the manufacture of Peptides and Oligonucleotides
Experience in GMP manufacturing as well as basic knowledge of cGMP and FDA regulations
Knowledge of SAP, Master Control and other quality and ERP systems
We Offer
You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are
looking for a new challenge and want to join a motivated team in an internationally renowned company,
you should seize this opportunity.
Nearest Major Market: Los Angeles
The Chemist II (Chem. II) function is to work in a cGMP-regulated environment manufacturing active
pharmaceutical products (APIs) as well as performing related activities at Bachem.
Your Tasks
Install, operate and maintain equipment for manufacturing and in-process testing. The equipment includes but not limited to analytical HPLC/UPLC, prep. HPLC systems, lyophilizes, balances, reactors, HF cleavage equipment, diafiltration systems, water purification systems, ovens, washing systems and others used in manufacture
Perform solid phase and liquid phase synthesis, deprotect and cleave the API from the resin using chemical cocktails, containing HF, TFA, ammonium hydroxide or other chemicals
Perform purification process by chromatography, crystallization and other techniques
Follow approved GMP manufacture directions such as Master Batch Production Records (MBPRs), Standard Operation Procedures (SOPs), Standard Test Procedures (STMs) and other procedures to manufacture GMP materials, perform in-process test, package intermediate as well as final products and 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
Follow and maintain GMP Documentation System. Initiate, investigate and closure of deviations, CAPAs, investigations, reports and related documents
Routinely maintain/organize work areas (Hood, bench, floor, wall, etc.) and other designated areas at the manufacturing facility
Help write and suggest improvements for Standard Operation Procedures (SOPs), Standard Test Procedures (STMs), Master Batch Records (MBPRs) and other related GMP documents
Follow SOPs and approved directions to clean equipment, glassware used in GMP processes and maintain cleaning logs for each equipment. Dispose of 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
Takeover housekeeping ownership of production equipment and rooms
Help quality control and assurance unit to maintain equipment calibration, qualification and maintenance program
Assist in the development of peptide-manufacturing processes including peptide/protein purification by chromatography, crystallization, and other techniques, and in process test methods
Assist in the development processes for synthesis and purification of chemicals other than APIs
Train other operators on SOPs, equipment and operations required on the shop floor
Ensure all equipment being used for the project is adequately labeled with the status of the equipment
Your Profile
Minimum of 3 years' work experience
Bachelor's Degree in Chemistry or related field
Experienced in cGMP manufacturing
Maintaining good housekeeping
Excellent written and oral communication skills
Communicate effectively and ability to function well in a team environment
Ability to communicate in a proactive and solution-focused manner, including keeping direct supervisor aware of potential issues
Flexibility of working hours based on business needs, may include some nights and occasional weekends
Ability to work independently and manage one's time
Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
Detail oriented with the ability to troubleshoot and resolve problems
Good computer knowledge, including Microsoft Word, Excel and PowerPoint
Experienced using analytical HPLC/UPLC, prep HPLC system, lyophilizers, balances, solid as well as liquid phase reactors, HF cleavage equipment, diafiltration systems, water purification systems, oven, washing systems and other equipment used in manufacturing
Experienced in working in a clean room environment (ISO 7 & ISO 8 classified rooms)
Capable of qualifying equipment and performing routine maintenance on equipment
Capable of training other operators
Work with hazardous materials and chemicals
Preferred:
Experience in the manufacture of Peptides and Oligonucleotides
Experience in GMP manufacturing as well as basic knowledge of cGMP and FDA regulations
Knowledge of SAP, Master Control and other quality and ERP systems
We Offer
You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are
looking for a new challenge and want to join a motivated team in an internationally renowned company,
you should seize this opportunity.
Nearest Major Market: Los Angeles
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