Science, Pharmaceutical & Food
Technical Services Manager
- Dublin North
PE Global is currently recruiting for a Technical Services Manager on behalf of our client based in Dublin. This is an initial 12 month contract role.
- The successful candidate will be responsible for technical oversight at Contract Manufacturing Organizations (CMOs) to produce commercial and clinical small molecule Drug Product.
- This position provides strong scientific leadership for all aspects of technology transfer, validation, process scale-up, process monitoring, and process troubleshooting for Oral Solid Dosage (OSD) manufacturing activities at CMO’s. Additional knowledge of fill finish and or packaging manufacturing would be an advantage.
- The position also fosters effective cross-functional working relationships with internal and external groups in operations, process development, analytical sciences, and quality assurance for the technology transfer of new and existing products and providing support for regulatory submissions related to commercial and clinical small molecule Drug Product manufactured at CMOs.
- Act as subject matter expert for Oral Solid Dosage (OSD) processes, including technology transfer, process evaluation, problem solving and investigation at CMOs during multiple NPI and product launch programs.
- Provide guidance to process validation program for OSD manufacturing processes at CMOs.
- Provide technical input to process development for defining the critical process parameters of new processes.
- Provide technical direction for the identification and implementation of process optimization initiatives as well as efficiency and capacity improvements at CMOs.
- Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
- Support the generation and review of CMC sections of NDA and other technical documents for regulatory agency submission for commercial CMO sites.
- Provide significant technical depth to support continuous process improvement to maximize yield and lower cost of goods (CoGs).
Education and Experience:
- Minimum undergraduate degree in a scientific discipline (Chemistry, Biochemistry, Pharmacy), Engineering (Chemical, Mechanical) or related field.
- A minimum of 6 years’ experience in the pharmaceutical industry with a strong technical services/MSAT experience.
- Working knowledge of solid oral dosage manufacturing to enable problem solving and identification of process improvements.
- Demonstrated ability to project manage technology transfer and/or new product launches.
- Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
- Lean six sigma experience is preferred.
- Knowledge of Quality by Design (QbD) principles, including the use of multivariate data analysis and/or first-principles process modelling in conjunction with predefined multivariate operating ranges (“Design Spaces”) in a commercial manufacturing setting.
- Knowledge of basic statistical principles and exposure to statistical software packages (e.g., Minitab, JMP)
- Exposure to/experience of Project Management principles and tools
- Exposure to/experience of MS Project or other project management software
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 email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***