Cambrex-posted 8 months ago
$31 - $35/Yr
Full-time • Entry Level
Niwot, CO
Merchant Wholesalers, Nondurable Goods

The Associate Scientist, Manufacturing will work within a team to perform kilogram scale organic synthesis of pharmaceutical drug substance. The Associate Scientist will operate chemical manufacturing equipment and execute detailed written instructions from a batch record under Good Manufacturing Practice (cGMP) conditions. In addition, the Associate Scientist is responsible for maintaining the manufacturing suites for activities by properly setting up, breaking down, operating, and cleaning production equipment for both GMP and non-GMP drug substance manufacturing operations. An Associate Scientist in manufacturing will operate under and develop subject matter expertise in cGMP practices and Good Documentation practices (GDP) within the Quality Management System.

  • Performs basic to intermediate scale-up chemical synthesis and manufacturing operations of drug substance with manager supervision.
  • May contribute and support process development in the R D labs as needed with supervision.
  • Properly sets up, operates, breaks down and cleans production equipment per written procedures.
  • Maintains cGMP suites to be tour/audit ready and prepared for manufacturing activities.
  • Understands and follows detailed written procedures.
  • Consistently, clearly, and accurately documents activities in production records and laboratory notebooks in accordance with Good Documentation Practices (GDP).
  • Performs routine equipment maintenance/preventative maintenance activities.
  • Identify, stock and requisition equipment/parts as needed for manufacturing processes.
  • Works with or around hazardous chemicals and waste in the chemical manufacturing environment.
  • May perform other duties as assigned.
  • BS in chemistry or related field with 0-3+ years relevant experience, or equivalent combination of education and experience.
  • Basic understanding of undergraduate chemistry, mathematics and the scientific method.
  • Basic understanding of cGMP and GDP requirements for drug substance manufacturing.
  • Some experience operating in a GMP environment is considered a plus.
  • Good aptitude for setting up and operating chemical reaction and manufacturing equipment.
  • Knowledge of equipment and facility maintenance for the GMP and non-GMP production is a plus.
  • Good chemical processing skills, including chemical weighing, basic to intermediate calculations, detailed record keeping, vacuum/pressure pumps, filtration techniques, distillation principles, etc.
  • Ability to wear respirators and various types of PPE while promoting a safe work environment.
  • Willingness to handle and work with hazardous chemicals and chemical waste in a safe environment.
  • Able to read and comprehend detailed written instructions.
  • Must adhere to the Cambrex attendance policy.
  • Effectively communicates both verbally and in writing.
  • Able to work independently or within a team environment with supervision.
  • Shows initiative and does tasks without being asked.
  • Undergraduate organic chemistry experience is considered a plus.
  • Some experience operating in a GMP environment is considered a plus.
  • Healthcare
  • Life insurance
  • Planning for retirement
  • Competitive benefits package
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