Senior Manager, CDMO-CTO Relationship Management

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OBJECTIVE:

Accountable for Contract Development Manufacturing Organization (CDMO), Contract Testing Organization (CTO), and medical device supplier management and leadership to support clinical manufacturing and analytical testing activities. Recognized expert in managing the logistical and operational aspects of assigned projects and/or processes. The position requires in-depth interactions with scientists, quality specialists from various departments, and external vendors.

ACCOUNTABILITIES:

• Lead the relationship management activities for outsourced global projects with multiple internal and external work streams (drug substance, drug product, logistics, etc.) and integrate implications for any external operations opportunities across a variety of modalities.
• Accountable for supporting the assessment and evaluation of CDMO, CTO and vendor capabilities critical for successful delivery of Takeda’s clinical development portfolio, in partnership with PS Functional SMEs.
• Accountable for establishing working partnerships between Clinical Supply Chain and the broader PS organization to clarify roles and responsibilities between Clinical Supply Chain, Functional SMEs, and Procurement in establishing and maintaining CMO- CTO/vendor alignment that addresses the needs of the current and anticipated development pipeline.
• Establish best practices, set and maintain high performance standards across the vendor network, and establish mechanisms for early identification of poor Vendor/CMO-CTO performance, and work to address. Establish and monitor continuous improvement initiatives and performance measures with external network.
• Act as an operational liaison between Clinical Supply Chain and stakeholders, Takeda partners, and contract manufacturing organizations. Effectively engage with key stakeholders (internal and external) to ensure timely implementation of project objectives. Identify interdependencies and connections between departments and ensure integrated end to end visibility and alignment.
• Provide a single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CDMO-CTO governance structure.
• Demonstrate an understanding of company priorities, objectives and project timelines. Define and manage critical path, proactively identify and escape issues and help resolve them.
• Develop and manage mutually beneficial, long-term business relationships with CMOs-CTOs.
• Demonstrate strategic thought and resource planning to support multi-geographic programs and personnel.
• Identify and communicate opportunities for change; plans for team to meet new challenges.
• Lead and support Clinical Supply Chain business initiatives and facilitate their implementation with appropriate stakeholders.
• Effective communicator with the ability to guide and influence a wide range of stakeholders without having formal authority over final decision.

EDUCATION,

EXPERIENCE AND SKILLS:

• BS and 7+ years’ experience or advanced degree and 5+ years of experience
• Must have exceptional working knowledge of CMC operations relating to research and development and investigational drug manufacturing. Must have direct management experience with external contract manufacturing organizations.
• Demonstrated excellence in project management and effectively managing multiple projects/priorities.
• Act as the key contributor in authoring Statements of Work in and insuring contractual alignment post RFP award.
• Experienced in contractual requirements and implementing systems and processes for support of cross-functional activities.
• Must have strong PC experience along with expert in MS Office suite applications.
• Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information.
• Ability to work well…