Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
Hovione is making a definite move into Continuous Manufacturing with a state-of-the-art facility in New Jersey and is now hiring. We are looking for strong professionals for this exciting and innovative project.
We are recruiting for the following position at our U.S. site located in East Windsor, NJ:
The PAT Scientist will support the development and commercial manufacturing activities for continuous processes using PAT for control and real time release testing. The successful candidate will be responsible for developing, implementing, and maintaining spectroscopy methods using multivariate models as part of an enhanced process control strategy, including Real Time Release testing, under cGMP and following a Quality by Design approach.
- Develop, implement, and maintain spectroscopy methods using multivariate models as part of an enhanced process control strategy, including Real Time Release testing, under cGMP and following a Quality by Design approach;
- Support of development and commercial manufacturing activities for continuous processes and using real time release testing;
- Design and execution of PAT based experiments for process and product understanding aiming at process development, troubleshooting, and continuous improvement;
- Process data analysis and statistical process control;
- Select and define requirements for acquisition, and take technical ownership of process analytical equipment;
- Identify and lead the efforts for adopting new technologies and approaches related to PAT and Quality by Design to better fit the Company needs and challenges;
- Raise the company profile through written papers and presentations/workshops at conferences;
- Author development protocols and technical reports.
- University degree in the field of Engineering or Science, preferably Chemical or Pharmaceutical Engineering, M.Sc. + at least 6 years, or Ph.D. + at least 2 years of relevant work experience;
- Proficiency in spectroscopy method development (NIR, RAMAN, Mid-IR);
- Experience in developing, implementing, and maintaining multivariate models across spectroscopy methods, as part of an enhanced process control strategy, including Real Time Release testing;
- Experience in developing and applying Process Analytical Technologies for Drug Product manufacturing to support QbD and Continuous Improvement Knowledge in following a Quality by Design approach, Design of Experiments, statistical analysis, and risk management.
- Familiar with methods for physical characterization of powders and tablets (laser diffraction, XRPD, flowability, etc.)
- Previous experience in continuous manufacturing will be favored;
- Results driven, team player, able to deal with multiple projects/tasks;
- Analytically minded and problem solving attitude;
- Flexible, autonomous and able to take ownership;
- Good communication skills.
- Full time opportunity;
- Remuneration and social benefits adjusted to the job function and matching the experience;
- Excellent work environment, with a strong focus on quality.