Johnson & Johnson Careers
Requisition ID: 00001F06
General Objective & Responsibility:
• 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:
• 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 CMO’s
• 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
J&J (China) Investments Ltd (7046)