契約開発・製造 シニアマネージャー/ Contract Devt & Manufacturing Sr. Manager

A global pharmaceutical company is looking for a Contract Development and Manufacturing Senior Manager. The selected candidate will oversee contract manufacturing projects, ensure compliance with cGMP standards, and drive operational excellence across development and commercial programs.

Responsibilities:

• Lead external development and manufacturing projects for Synthetic DP/FDP and Biologics DP/FDP modalities
• Collaborate with functional leads in Drug Substance, Analytical, Quality, Supply Chain, and Strategic Sourcing
• Build and maintain positive relationships with internal and external stakeholders to enhance program efficiency
• Manage multiple assignments independently and identify project optimisation opportunities
• Monitor supplier performance and maintain external collaborations to improve efficiency and effectiveness
• Oversee purchase orders, budgets, and financial forecasting for externalisation activities
• Ensure projects meet compliance, quality, speed, and cost objectives
• Contribute to ACDM knowledge development by assessing industry trends and the contract manufacturing landscape
• Drive risk management, operational excellence, and other key Operations initiatives
• Travel 20% domestically and internationally

Requirements:

• Bachelor’s degree or above
• 2-12 years of Manufacturing or Operations experience
• Ability and willingness to travel
• Professional level English and Japanese

Preferred requirements:

• More than 8 years of proven experience in pharmaceutical manufacturing, including drug development, manufacturing, and commercialisation for Synthetic DP/FDP and Biologics DP/FDP
• More than 8 years of working knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
• More than 5 years of demonstrated ability working with external parties and leading cross-functional teams for clinical and/or commercial products
• More than 3 years of project management experience leading multi-functional and multi-location teams
• Experience interacting with domestic and international suppliers, including CDMOs/CROs and import/export policies

About the Company:

A global pharmaceutical group, this organisation is an internationally recognised name in biotechnology. Responsible for a range of medicines aimed at treating human illnesses, this company supplies medical professionals and patients across the world.

Keywords:

製薬, バイオテクノロジー, 契約製造, プロジェクトマネジメント, 外部委託, クロスファンクショナルチーム, 求人, 外資系

Job Ref: 2ZUERM