Production Chemist II

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