External Manufacturing Associate Manager

Job Details

<Job Title>

17667 External Manufacturing Associate Manager

<Job Descriptions>

The role of this position is to select external contractors for development and production and to lead their management and coordination. This position will also be responsible for proposing and implementing measures to improve the efficiency, quality, and yield of regenerative cell medicine production. Specific responsibilities are as follows.
・Manage and oversee operations at Contract Manufacturing Organization (CMO) to ensure on-time quality product meeting quality, compliance, and regulatory
requirements.
・Responsible for the timely execution of Technology Transfer plans to CMO in
preparation for clinical trials and commercialization.
・Ability to build trust and garner positive relationships as Person in Plant at CMO.
・Establish and manage MSA, SOW, and other manufacturing agreements.
・Possess a thorough knowledge of Quality Management Systems. Ensure timely
closure of deviations, CAPA, and implementations at CMO.
・Effectively communicate changes and resolve issues with CMO.
・Proactively develop manage, track, and improve CMO performance. Set milestones and monitor KPIs. Report out CMO Manufacturing updates.
・Collaborate with Supply Chain to develop and monitor site budgets.
・Lead and/or participate in cross functional Technical Operations projects to ensure the company’s objectives.
・Other duties as assigned

<Requirements>

・Bachelor’s degree in Life Sciences or related field with a minimum of 5 years of
directly related GMP pharmaceutical manufacturing experience.
・Knowledge of pharmaceutical cell therapy processes.
-Direct GMP aseptic cell culture experience is a major plus.
・Languages: Fluent in both English and Japanese
・Technology Transfer experience required.
・Financial acumen is required for working with operational budgets and budget
planning.
・Ability to collaborate cross functionally in a function.
・Project Management experience is a plus.
・Ability to work independently and as part of a team.
・Ability to travel as needed. Approximately up to 25% travel.
・Candidates must be authorized to work in Japan.

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