Process Development Engineer

5 days ago


Georgetown, United States AustinPx Pharmaceutics and Manufacturing Full time
About AustinPx Pharmaceutics and Manufacturing

AustinPx Pharmaceutics and Manufacturing is a contract development and manufacturing organization (CDMO) providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol Technology.

Job Summary

We are seeking a highly skilled Process Development Engineer to join our team. As a Process Development Engineer, you will work within a cGMP quality system, participating in manufacturing activities under limited supervision. You will complete process development and scale up activities in collaboration with formulation development and manufacturing to enable clinical trial material manufacturing.

Key Responsibilities
  1. Work within a cGMP quality system, including participating in manufacturing activities under limited supervision.
  2. Complete process development and scale up activities in collaboration with formulation development and manufacturing to enable clinical trial material manufacturing.
  3. Utilize statistical design of experiment and process control schemes to optimize outcomes.
  4. Solve technical issues relating to the manufacture of dose form/product using process analysis tools.
  5. Design Experiments to investigate the relationships between material attributes, process parameter/equipment selection, and product quality.
  6. Generate process development/optimization protocols and reports.
  7. Assist with all necessary activities to procure and install equipment, including developing requirements, setting up, qualification protocol writing & execution, SOP development.
  8. Scale up of manufacturing processes from pilot to commercial scale.
  9. Participate in process technical transfer of manufacturing processing to 3rd party Contract Development and Manufacturing Organizations (CDMOs) to enable commercial manufacturing.
  10. Travel to CDMOs to oversee process transfer and manufacturing.
  11. Develop a strong understanding of specific equipment utilized internally and at CDMOs.
Requirements
  1. Understand drug formulation, analytical results, drug product manufacturing conventions.
  2. Complex problem solving and troubleshooting.
  3. Strong, proactive communication and interpersonal skills.
  4. Ability to interface effectively with a variety of stakeholders.
  5. Advanced decision-making skills.
  6. Organizational skills required.
  7. Strong multi-tasking skills required.
  8. Pharmaceutical background required.
Qualifications
  1. Bachelor's Degree in Engineering, Chemical Engineering preferred.
  2. 0-2 years in solid oral dosage form process development.
  3. GMP or Pharmaceutical experience preferred.


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