Principal Scientist
Principal Scientist
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Job Description
Assignment covers:
Co-ordinate Execution of Clinical batches as per plan across ESI network in Asia.
Process Engineering expertise input to the Drug Product Development teams
Due diligence assessments of CMO for clinical trial material manufacture including equipment and facility assessments to confirm capability for formulation fill finish and clinical packaging.
Support optimizations and / or changes to existing equipment
E2E responsibility for the manufacture of clinical trial material meeting the clinical demand schedule.
Tech Transfer support includes commercial plant readiness for registration launch and commercial production DoE & Scale-up support
Specific Objectives & Responsibilities:
Compliance responsibilities:
Project management:
Setup of the required cross-linked information platforms (QA Manufacturing Prevention PDMS/JSC)
Review Master Service Agreement and define Scope of Work at CMO
Define and follow-up on project FTE and budget planning
Follow-up on orders and invoicing according to project plan
Periodic review and score card monitoring of CMOs
Budget responsibilities:
Personnel responsibilities:
External contacts:
Internal contacts:
Profile/skills
Should be expert in Downstream manufacturing process in Large (Biopharmaceutical) molecule with an in-depth knowledge of Equipment and Facility used.
Specific expertise: scale-up/ technology transfer / Clinical Manufacturing/Process Engineering & in biopharmaceutical production
Elementary technical background (mechanics electrical PLC )
Preferably Biopharmaceutical or Pharmaceutical degree or equivalent with at least 5 years in pharmaceutical area.
GXP Regulatory requirements including CFDA guidelines Engineering Technical Standards for Biopharmaceuticals Technical Safety Standards Industrial Hygiene Standards MS office applications
Excellent knowledge of English (spoken and written)
Willing to travel (up to 40%)
Specific know how of systems
Elementary concepts of Facilities HVAC and Utilities
IPC and monitoring systems.
Basic concepts of CSV (computer system validation) systems.
Equipment qualification validation and change management systems.
Specific tools such as ATS (analytical trouble shooting) PE (process excellence tools) Planning tools (MS-project)
Good documentation practices
Required Experience:
Staff IC
Employment Type
Full Time
