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Process Development Scientist I
Fort Collins, CO

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Direct Hire

We are recruiting for this exciting direct hire Process Development Scientist I position for one of our top clients! Please apply if you are interested!

Role Description

Design and implement manufacturing processes, instrumentation and equipment from the laboratory through the pilot plant and manufacturing scale-up. Assists the manufacturing operation in problem-solving with regards to equipment and systems. Ensures manufacturing activities are designed and implemented to meet Quality and CMC-Regulatory requirements. Develops and recommends new process technologies to achieve cost-effectiveness and improved product quality.


  • Conduct process research, develop product/process optimization and/or improve procedures.
  • Development of pharmaceutical processes utilizing Quality by Design (QbD), risk assessment concepts, and appropriate manufacturing trials using Design of Experiment (DOE). Work with project teams to select and validate process equipment (including filling/packaging).
  • Develop and oversee scale-up studies and create controlled documentation (e.g., batch records) for products transferred from development to manufacturing.
  • Troubleshoot manufacturing problems and provide technical support and technical training to manufacturing personnel.
  • Identify, design and conduct transfer and manufacturing implementation activities to meet relevant Quality and CMC-Regulatory expectations.
  • Interface with Marketing Partners, Quality, Development, Regulatory and Business personnel.
  • Prepare validation protocols and reports, product and process technical transfer packages, and standard operating procedures.
  • Provide training and mentorship to junior process engineers.
  • Conduct process development activities together with Process Engineers to achieve project goals.
  • Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
  • Perform various other duties as assigned.

Knowledge, Skills & Abilities

  • Demonstrated success in process development, having a formulation development background covering multiple pharmaceutical formulation types.
  • Experience in scale-up of emerging technologies in injectable dosage forms.
  • Demonstrated solid leadership when working on complex problems within formulation development and process tech transfers in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Excellent oral and written communication skills demonstrated through interactions internally and externally with marketing partners, vendors, and legal counsel.
  • Strong technical writing in multiple areas, including controlled documentation, protocols and reports, justification and positions papers, and regulatory submission for CMC.

Core Values

The Process Development Scientist I it is expected to operate within the framework of the client’s Core Values:

  • Consistently operate with the highest standards of ethics and compliance.
  • Take ownership of your actions, success and setbacks.
  • Respect each other and understand that honest collaboration is at the heart of our company success.
  • Go the extra mile to make things happen.
  • Be committed to all we do and the patients we serve.
  • Embrace change with enthusiasm.
  • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

  • BS, Masters, Ph.D. in Chemistry, Biochemistry or Pharmaceutical Sciences required combined with BS: 5-8 years; Masters: 2-5 Ph.D.: 0-2 year’s process/formulation development experience.

Working Conditions

  • Laboratory and manufacturing setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
  • Some travel may be required.

Location: Fort Collins, CO


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