Dir PTS External Manufacturing, AsiaPAC Job

Date: Dec 25, 2018

Location: Shanghai, 31, CN

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Requisition ID: PRO018559


Summary of Position:


This position ensures that technical projects for Small Molecules products at MSD contract manufacturing organizations (CMOs) are managed with a consistent approach and on a timely basis, in line with the MSD Animal Health strategy, according to Global Supplier Management (GSM) priorities, and in compliance with External Manufacturing Quality Assurance (EMQ) requirements including applicable regulatory requirements.


 


The position holder is responsible to lead cross-functional teams of internal and external persons in the execution of approved technical projects at CMOs such as new product introductions from R&D, technology transfers (including applicable methods transfers) to CMOs, API-related changes, process improvements, process validations, and other-related technical projects


 


The position holder is able to act as a team leader and can be held responsible for the performance and/or start-up of a new and/or difficult process technology assignment.


 


The manufacturing sites that are supported by the person in this position include CMOs in Asia Pacific region such as China, Japan, Taiwan, etc..


 


The position holder will have to travel up to 30% of his/her time.


 



 


Major Assignments:


 


1.   Provide technical oversight, planning, coordination and support to CMOs for projects related to:


 


                      i.     R&D-to-CMO product transfers


                    ii.     Site-to- or CMO-to-CMO product transfers


                    iii.     API- and excipient-related changes


                  iv.     Process-related changes


                    v.     Technical trouble-shooting to support complaints and failures


                  vi.     Process Robustness efforts


                  vii.     Life cycle management support


                viii.     Process Performance Qualification & Continue Process Verification


                  ix.     Overarching changes to products or materials.


 


2.   Support GSM in supplier assessments, supplier due-diligence, and supplier improvement efforts


 


3.   Interface/support governance processes


                      i.     CMO Governance


                    ii.     Transfer Review Board where applicable


                    iii.     API Governance


                  iv.     External Manufacturing Quality Council


 


4.   Support consistent organizational processes and communications


                      i.     Connectivity


                    ii.     Reliance change control


                    iii.     Qualification/validation approaches


 


5.   Support of direct knowledge transfer between the manufacturing sites, support of development of global key technology platforms, technical expertise and MSD technology network.


 


6.   Facilitation of communication and interface for CMOs to other global departments such as Supply Chain Management, Regulatory Affairs, Commercial Operations/Marketing and Pharma R&D.

Qualifications



Skills:




  • Degree in Science (Process technology, Pharmaceutical technology, Industrial Chemistry, Food technology,…) and at least 10 years of experience in technology or manufacturing position in a Pharmaceutical, Food manufacturing or Fine chemicals producing company or in extended experience in an academic environment of Pharmaceutical/Chemistry departments.

  • Business Experience in projects as technology transfers will be asset. Business degree a plus.

  • 5 years of experience in high-level project management of technical projects at GMP manufacturing sites

  • Regulatory background incl. applicable AsiaPAC health authority requirements or motivated to acquire this quickly.

  • Strong knowledge of GMP requirements or motivated to acquire this quickly.

  • Experienced in internal business processes and organization.

  • Language requirements: Fluent Chinese and English



Job: Project Management Generic
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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