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Job Description:
This role is a key position responsible for leading the projects/initiatives for Suzhou which are led by TS/MS and/or contributed by TS/MS, for example leading post OQ, process validation activities for the Suzhou Line 2 Cartridge Filling Project, dual source localization materials/components supply projects, as well as site level and flow team level projects/initiatives coming from continues business needs.
The primary objective is to lead the team to deliver projects on time, with a focus on Safety First and Quality Always. The PM Lead will lead development post- OQ strategies, coordinate multi-functional teams internal and external TS/MS, manage resources, and ensure all activities are compliant and efficient.
Key Objectives:
Lead from TS/MS the site level and flow team level projects/initiatives, including:
Dual source localization materials/components supply projects, cover all raw material, excipients and PPC for relevant products produced in Suzhou.
Yield optimization project for Suzhou site, etc.
Support PP team on product tech transfer and commercialization.
Proactively coordinate and resolve issues across different functions to meet project milestones.
Proactively take corrective actions to mitigate potential delays arising from any project issues.
Manage and collaborate closely with SA, PP, VA team to utilizing the team resource to ensure business demand can be meet quickly and flexibly.
Upcoming projects/initiatives to ensure continues and sustainable business needs.
Lead Line 2 project starts from post- OQ to APS to product PV, including:
Lead development post- OQ strategies, timeline, including formulation system, filling line, cleaning room, autoclave, parts washer etc., benchmarking the best practice from Fegersheim and Sesto and IPM site, define the preconditions for each key system/equipment for each validation phase.
Coordinate multi-functional teams internal and external TS/MS, manage resources to ensure project milestones, e.g. FAT, IOQ supporting from TS/MS, and onsite activities management.
Organize and support PQ and PV activities including VMP, PQ/PV Protocols and Reports, e.g. cleaning validation, sterilization validation, EMPQ, AFPT and APS planning.
Support tech transfer activities to ensure the PV timeline based on business needs.
Support commercialization, regulatory filing, GMP inspection/certification.
Support training and knowledge transfer to develop people’s skills, capability and capacity.
Build a capable and sustainable project team,
Develop and manage team member’s PM program.
Manage team member’s training and development programs, effective in retaining key talents.
Support global project management, train and prepare appropriate team members for STA/LTA
Accept the delegation from supervisor.
Basic Requirement:
Bachelor's degree or above in pharmaceutical, chemistry or chemical engineering or related fields.
Above 8 years’ experience in pharmaceutical industry, with capital project or greenfield management practical experience.
Familiar with GMP knowledge and practices with relevant experiences.
Effective leadership skills.
Strong teamwork and collaboration.
Very strong communication skills and networking skills.
Solid English communication skills.
Good computer skills. Prefer strong aseptic drug product process knowledge and validation experience
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