CDMO-CTO Management Strategy and Operations Director

Role Summary

CDMO-CTO Management Strategy and Operations Director. Location: Lexington, MA. Hybrid work arrangement.

Responsibilities

• Support alignment of strategic supplier base with network strategies, Future Fit, Digital Readiness, and Innovation needs, working closely with each PharmSci R&D function (Drug Product & Device Development, Analytical Development, Biologics Process Development, Synthetic Molecules Process Development, and Program Leadership).
• Develop and maintain CDMO-CTO Management’s Vendor Network Strategy through continuous governance and evaluation of performance, effectiveness and strategic fit of vendors selected.
• Continually optimize and socialize CDMO-CTO Relationship Management operating model and standardize supplier-centric processes to maximize efficiencies with internal stakeholders (PharmSci Technical functions, Legal, Finance, Procurement, Global Manufacturing Services) and strategic external suppliers.
• Create and maintain necessary GXP documentation and trainings on operating model.
• Support ongoing management and oversight of existing critical vendors including performance management, KPIs, business/financial risk evaluations, and governance.

Qualifications

• Bachelor Degree in Engineering, Biotechnology, Business or scientific field. MBA or Masters Degree preferred.
• Minimum of 10-15 years of relevant clinical/commercial drug, device, and/or combination product Pharmaceutical experience.

Skills

• Strong relationship-building with internal stakeholders to facilitate operating model awareness and consistency.
• Ability to proactively identify program/portfolio risks and develop robust mitigation and contingency plans.
• Professional ability to identify, action, or elevate internal and external supplier issues and conflicts in a timely manner.
• Capacity to partner with stakeholders to select among existing or develop new CDMOs to meet program requirements and augment manufacturing network capabilities.
• Establish clear and consistent supplier governance models, meeting cadence, and escalation paths.
• Ability to establish and support global network/supplier strategies aligned with R&D function needs and long-term goals.
• Critical review and problem-solving skills for complex business challenges, with the ability to propose potential solutions.

Education

• Bachelor Degree in Engineering, Biotechnology, Business or scientific field. MBA or Masters Degree preferred.
• Minimum of 10-15 years relevant clinical/commercial drug, device, and/or combination product Pharmaceutical experience.

Additional Requirements

• This position is classified as “hybrid” by Takeda’s Hybrid and Remote Work policy.