Job Description
Process Engineer/Scientist required to work within the Process Development Commercial Support team at a client site, providing process and product support to drug product formulation and fill-finish operations.
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA. We operate globally in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide.
Job Description
The Process Engineer/Scientist will act as a drug product process development technical expert, providing swift and innovative solutions to complex challenges in drug product formulation, vial filling, pre-filled syringe filling, lyophilization, and vial capping.
- Assess product impact associated with proposed changes to commercial processes under the change control process.
- Generate product impact assessments associated with process excursions and deviations, with reference to product technical documentation.
- Support new product introduction team as a process subject matter expert; this includes, but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support.
- Review and approve changes to operating procedures, electronic batch records, and product documentation.
- Identify and implement operational opportunities for current and new sterile operations risk assessments and mitigation projects relating to line performance.
- Perform process gap analysis and develop strategies to close gaps.
- Data trend analysis for all performance aspects of the area.
- Troubleshooting performance trends.
The chosen candidate will work in a collaborative manner within the process team's structure and contribute as a member of cross-functional teams within the local organization and functional team globally.
Requirements
- Bachelor's or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR Ph D and 3 years of directly related experience.
- Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling, or lyophilization. Qualification in Lean and 6-sigma methodologies would be an advantage.