A global leader in Bio-Similar pharmaceutical company is seeking a 'Production Manager' as follow;

[RESPONSIBILITIES]
1. Schedule manufacturing slot and necessary activities (i.e., procurement) at Contract Manufacturing Organizations (below; CMO) and other external service provider (below; supplier)
2. Identify and monitor key operational performance indicator for CMO (incl. other supplier)
3. Work as primary contact for innovation, investigation, and CAPA activities associated with CMO (incl. other supplier)
4. Closely communicate site quality issue (i.e., nonconformance, deviation, OOS, change control, compliant, and recall etc.) between QA and CMO (incl. other supplier) based on corporate quality management system
5. Verify suitability, qualification and validation of processes at CMO (incl. other supplier) to meet required time line with supply chain dept.
6. Support technical transfer activities or process characterization to implement site and process change management
7. Drive process innovation for manufacturing process with process analytical tool
8. Develop innovative solutions with CMO (incl. supplier) to reduce cost/delivery time and improve efficiency
9. Write technical reports on a variety of manufacturing-related subjects
10. Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical product.
11. Occasional travel (i.e., supplier visits) may be required.

[QUALIFICATIONS]
- Bachelors in Biology, Chemistry, Engineering, or relevant science
- 4-8 years of work experience in commercial biologics fill and finish manufacturing under EU and US cGMP
- Expert knowledge in process validation and technology transfer for protein drug product manufacturing
- Expert knowledge in aseptic process simulation
- Expert knowledge in particulate for parenteral product
- Expert knowledge in EU and US cGMP regulation
- French or Italian speaking is a plus
- Excellent verbal and written communication skills in English
- Familiar with Microsoft Office application (MS word, MS excel, MS project, and MS sharepoint)

Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently  Only qualified candidates will be contacted for interview  All resumes not contacted will be kept in DB confidentially for future positions

Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Phone: 02-557-8272
Mobile: 010-8722-1272
Email: ceo@exdigm.com