OSD External Technical Services Manager
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| Job Type | RemoteContractor |
| Area | DublinCork |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +353 98 33013 |
| Job Ref | #1002577 |
| Job Views | 312 |
- Description
- 2577 - OSD External Technical Services Manager
Team Horizon is seeking an OSD External Technical Services Manager who will be responsible for technical oversight at Contract Manufacturing Organizations (CMOs) used by our client to produce commercial and clinical small molecule Drug Product.
You will provide 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.
What you will be doing:
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 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).
Up to 20% international travel may be required.
What you need to apply:
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.
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.
Additional knowledge of fill finish and or packaging manufacturing would be an advantage