I am seeking an experienced Process Scientist in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping to join the Process Development Commercial Support team within a leading Biopharmaceutical company.
The team is responsible for providing process and product support to drug product formulation and fill-finish operations as drug product process SMEs *Hybrid role Key Skills necessary for this role: Process Development Experience - New Tech Transfer New product introduction or process improvement experience in a GMP environment would be advantageous Product and process investigation support - deviation or non-confirmative experience Continuous improvement projects to improve process performance and productivity Duties include: Act as a drug product process development technical expert to provide swift and innovative solutions to complex challenges 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.
Identifies and implements operational opportunities for current and new sterile operations 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.
The chosen candidate will work in a collaborative manner within the process teams structure and contribute as a member of cross functional teams within the local organization and functional team globally.
Qualifications & Experience: Bachelor's or Masters degree in Science, Engineering or related discipline with 3 - 6 years experience in a similar role OR Ph D and 3 years of directly related experience.
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.
Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
Skills: process scientist drug product fill finish process qualification product formulisation process gap analysis biopharmaceuticals