Drug Product Operations Specialist 

Bend, OR 

 

Do you: 

  • Like finding new and better ways to do things? 
  • Want to help develop medicines to make patients’ lives better? 
  • Desire to learn and grow? 
  • Nerd out on science & technology? 
  • Value people and working in a collaborative team? 
  • Desire to be audacious and entrepreneurial? 
  • Value safety and leading by example? 
  • Care about doing the right thing? 

At Bend Bioscience, we are looking for colleagues with: SCIENTIFIC CURIOSITY, HONESTY, HUMOR, CONFIDENCE, HUMILITY, TRUSTWORTHINESS, RESPECT FOR CO-WORKERS, and the DESIRE TO MAKE A DIFFERENCE AND HELP PATIENTS. 

 

Job Description:  

Bend Bioscience is focused on the development and clinical production of non-sterile drug products and intermediates for the pharmaceutical industry. In this role, you will be responsible for all functions related to the processing of oral drug products (tablets/capsules) in a Current Good Manufacturing Practices (cGMP) facility.   

 

The Drug Product Operations Specialist works collaboratively with other departments and will be responsible for development and clinical manufacture of pharmaceutical drug products, from product design to cGMP manufacture for clinical trials. Primary responsibilities: 

  • Operational subject matter expert for pharmaceutical unit operations including dispensing, blending, compaction, granulation, compression, coating, and encapsulation. 
  • Develop and write systems and procedures to facilitate cGMP operations including equipment assembly, operation, cleaning, and product changeover and ensuing execution. 
  • Write, execute, and review batch records according to good documentation practices while adhering to all safety, cGMP, compliance/regulatory, and quality requirements. 
  • Interact closely with product development to successfully transfer formulations and processes from development to clinical manufacture.  
  • Effectively communicate with cross-functional project teams during manufactures and as needed for technical support.  
  • Design strategy for and perform in-process product quality checks as required and document accurately.   
  • Identify and assist with investigations, corrective actions, and implementation of processing and manufacturing improvements. 
  • Perform warehouse related material flow and disposition requirements related to sampling, dispensing, and disposition of raw materials, in-process, and finished products.   
  • Identify and implement continuous improvement opportunities related to safety, operations, and quality.   

Experience and Educational Requirements: 

  • High School diploma or equivalent. 
  • Experience with assembly, operation, and cleaning of manufacturing equipment for oral solid dosage forms (immediate release tablets and capsules) in a cGMP setting.  
  • Ability to follow verbal and written instructions including SOPs and batch records. 
  • Proficient with Microsoft office applications including Word and Excel, as well as mathematical equations required for operations (e.g. addition, subtraction, multiplication, division, percentages, ratios, etc.).