HireDiversity

Guangzhou (Canton), CN

Production Manager-Guangzhou Bioseal Plant-000008DB

Description

The employee of this position will sign labor contract with Guangzhou Bioseal Biotech Co., Ltd.

• Solid understanding of pharmaceutical processing and control requirements. Prefer additional experience with Biopharmaceutical, (e.g. GMP) and aseptic processing.
• Strong technical expertise with pharmaceutical and or chemical processing, protein purifications, viral inactivation, aseptic processing, lyophilization and sterile liquid fill finish with vials.
• Perform technical due diligence and develop an integrated functional plan and organization for the manufacture operation.
• Facility, equipment and maintenance management
• Production activities activity and materials requirement planning management
• Capacity planning and utilization management
• Ability to work as part of a cross-functional, multi-national project team.
• Operational and facility design for new product introduction and launch.
• Ability to manage one or more projects and prioritize activities to align with the overall company objectives.
• Good working knowledge of SAP or other production control (IT) systems to support operations, quality (CAPA, Change Control, Documentation Control), maintenance and engineering and/or planning and logistics
• Deep expertise with process and equipment validation requirements. Lead Root Cause Analysis and technical trouble shooting. Good knowledge of Process Excellence (Six Sigma).
• Working knowledge of Compliance CAPA, Deviations & NCR Systems, Statistical Techniques, Quality Metrics and production/supply chain metrics.
• Handle complex capital projects and assures delivery of the improvements in a cross-functional, timely and cost-efficient manner.
• Proactively identifies, evaluates and implements process changes and improvements. Ensures proposed process changes are consistent with applicable regulatory requirements and assures changes that affect a regulatory submission or require communication to regulatory authorities are appropriately conveyed.
• Oversight to technical documentation required to upgrade existing process and internal controls.

Qualifications


• Bachelor's degree in Engineering, Master's degree a plus.
• Minimum of 7 years experience in plant level pharmaceutical or biologics operations.
• Knowledgeable of sFDA/EMEA/TGA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply China GMP regulations and other FDA and international guidelines to all aspects of the position.
• Excellent communication skills, English fluent a minimum, Mandarin fluency strongly preferred.
• Must have strong leadership experience with a track record of developing and mentoring teams.
• Experience with combination products is desirable.
• Demonstrated project management skills with strong ability to negotiate and influence in a highly matrixed environment.
• Strong organizational skills; ability to prioritize and manage through complex processes/projects.

Primary Location:Asia Pacific-China-Guangdong-Guangzhou (Canton)
Organization: Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function: Production