CDMO-CTO Management Strategy and Operations Director

Takeda • Lexington, MA

4d • Hybrid

About The Position

The Strategy and Operations Director owns the alignment of the supply base to PharmSci’s short and long-term goals. The Director works to maximize our organization’s efficiency and effectiveness by standardizing our processes to manage external partners and the engagement of our internal stakeholders. Works in close coordination and collaboration with CDMO-CTO Relationship Managers, the functions, and shared services (such as procurement, legal, and finance) to achieve Takeda’s objectives. Support alignment of strategic supplier base with our 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 our supplier-centric processes to maximize our efficiencies with our engagements with internal stakeholders (PharmSci Technical functions, Legal, Finance, Procurement, and Global Manufacturing Services) and our strategic external suppliers. Create and maintain necessary GXP documentation and trainings on operating model Support the ongoing management and oversight of existing critical vendors including performance management, KPIs, business/financial risk evaluations, and governance

Requirements

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

Nice To Haves

• MBA or Masters Degree preferred.

Responsibilities

• Represent CDMO Management on strategic initiatives such as clinical manufacturing site selection and capacity planning.
• Develop strategies to reduce the external manufacturing footprint by 10% year over year.
• Align the global vendor network strategies across categories, regions and business functions (including but not limited to Global Manufacturing Services, Global Procurement, Global Clinical Supply Chain, Legal)
• Develop a framework to capture network vendor performance through fit-for-purpose KPIs, translating to dashboards and operationalize a solution to enable continuous network optimization
• Build and manage a strategic road map across People, Process and Systems to standardize work and improve efficiency across CDMO-CTO team and the wider PharmSci teams
• Act as business process standardization and optimization SME. This includes: manage vendor governance meeting charters, templates and procedures; create, update and maintain procedures and processes for CDMO-CTO Relationship Management; update and socialize CDMO-CTO team operating model; update and optimize Site Selection process, inventory management etc.
• Help identify, onboard, and then manage the business relationship of our new and existing strategic suppliers in line with functional and network strategies.
• Establish a strategy to import CDMO data into Takeda’s data fabric to enable aspirational digital innovation
• Build / drive an optimal usage of existing system solutions to allow centralized production visibility across the internal and external vendor base, ensure inventory compliance, enable lot genealogy and provide an interface with finance, global clinical supply chain and technical functions.
• Plan and maintain a rolling annual calendar of vendor governance meetings (Business Review Meetings – BRMS, Joint Steering Committees – JSC etc) with CDMOs, CTOs and Medical Device suppliers and support internal vendor network governance meetings as well as manage engagement at trade shows like DCAT and CHPI,
• Provide support to Product Operating Model (POM) as required
• Create and maintain standardized processes for site selection, vendor performance review and governance to be utilized by CDMO Relationship Managers and socialize within Pharm Sci
• Serve on Pharmaceutical Sciences cross-functional workstreams as CDMO Management SME and represent teams responsibilities and strategies
• Establish strong relationships with team members and internal stakeholders to facilitate operating model awareness and consistency
• Work closely with PharmSci Leads, Analytical development, Device Development Leads, , and other internal business partners (Procurement, Finance, Legal, Global Manufacturing Sciences) to proactively identify program / portfolio risks and develop robust mitigation and contingency plans
• Proactively identify, action, or elevate internal and external supplier issues and conflicts in a professional and timely manner
• Partner with Takeda stakeholders to select among existing or develop new CDMOs who can meet program requirements and augment Takeda’s internal or external manufacturing network capabilities
• Establish clear and consistent supplier governance models to ensure clear lines of communication, meeting cadence, and escalation paths
• Establish and support global network / supplier strategies that align with PharmSci R&D function needs and expectations, short and long term strategies
• Ability to critically review, process and understand complex business challenges, provide potential solutions

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees