Process Scientist

Desired Skills: lyophilization,vial filling,syringe filling

The role:

PE Global is currently recruiting for a Process Scientist on behalf of a leading biotech company in Dublin South. This is an initial 12 month contract role.

Overview:

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 as drug product process SMEs

Responsibilities:

• 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.

Education and Experience:

• Bachelor’s or Master’s 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.
• 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***