Purpose
Process Engineer/Scientist required to work within the Process Development Commercial Support team. The team is responsible for providing process and product support to drug product formulation and fill-finish operations onsite as drug product process SMEs
Responsibilities listed below but primarily the Hiring Manager can foresee support will be needed for the following:
* Day-to-day operations support as a subject matter expert in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
* Key contributor to product and process investigations, responsible for assessing product and process impact.
* Leads continuous improvement projects to improve process performance and productivity.
* 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 would include 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.
* Risk assessments and mitigation projects relating to line performance.
* Perform process gap analysis and developing strategies to close gaps.
* Data trend analysis for all performance aspects of the area.
* Troubleshooting performance trends.
Qualifications:
* Bachelor's or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR PhD 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.
Preferred Qualifications:
* Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation
* Qualification in Lean and 6-sigma methodologies would be an advantage.
* New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.