16361570 – Engineering Management – Dublin Contractor

This role is a 12 Month contract with a view to extension.

Purpose

The successful candidate will be responsible for technical oversight at Contract Manufacturing Organizations (CMOS) used to produce commercial and clinical small molecule Drug Products. 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 CMOS. 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 provides support for regulatory submissions related to commercial and clinical small molecule Drug Products manufactured at CMOS.

Responsibilities

• 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. Additional knowledge of fill finish and or packaging manufacturing would be an advantage.

• 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 the operational status of CMOs regularly to management, as required, at the appropriate level of detail. Communications will be both written documents

and 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 the cost of goods (CoGs).

• Up to 20% international travel may be required.

Requirements

• A minimum of 6 years of experience in the pharmaceutical industry with strong technical services/MSAT experience.

• Working knowledge of solid oral dosage manufacturing to enable problem-solving and identification of process improvements.

• Ability to start up and lead cross-functional teams in the resolution of short-term issues or sustained performance for long-term goals.

• Demonstrated ability to project manage technology transfer and/or new product launches.

• Strong communication skills enabling him/her to influence both internal and external partners.

• Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.

• Minimum undergraduate degree in a scientific discipline (Chemistry, Biochemistry, Pharmacy), Engineering (Chemical, Mechanical), or related field.

• An advanced degree (MS, PhD) is desirable.

• Lean six sigma experience is preferred.