Production Chemist II API II BSD

Employer
Bachem
Location
Vista, CA, US
Posted
Nov 03, 2020
Ref
630327501
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
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.

I 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: San Diego