External Supply Lead, Associate Director

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda''s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: External Supply Lead, Associate DirectorLocation: Lexington, MAThis is Hybrid Workplace Position: 2 days per week onsite is requiredAbout the role:Ensure the uninterrupted supply of drug products and finished goods from external suppliers which meet all quality requirements to support the oncology and small molecule market demands in the region and countries being supplied from suppliers in the region. Develop regional supply chain strategies, and manage supplier metrics and projects in the region. This will be accomplished through planning and on-time execution of highly visible/strategic projects, commercialization plans, commercial CMC support, QA initiatives, and developing/ implementing supplier management strategies. The scope of this role includes responsibility for the following activities: External supplier management for drug products and finished goods for the full small molecule portfolio, including Oncology, in partnership with Procurement Coordinate team activities for launches for small molecule and Oncology from suppliers in the region Continuous improvement strategy and execution for suppliers in collaboration with the operating unit Organize technical services supporting product improvements and technical/QA-related issue resolution at external suppliers for bulk products and finished goods. Product ownership of products not being actively managed by Product Operations. How you will contribute:Lead and manage the strategic and operational performance of external suppliers with direct responsibility for operations and partnership with the Quality and functional business partners to ensure the successful delivery of business strategy, key performance indicators (KPIs), and objectives Anticipate roadblocks, both intellectual and political, and proactively address issues before they impact business results Use expertise to influence strategy, planning, manufacturing, and supply chain processes Establish a process for periodic review and dissemination of information that represents the health of the supplier and performance against KPIs to key leaders and stakeholders Support site selection process to ensure consistency with commercial strategy Maintain senior-level communication lines with all sources of demand and supply Lead the External Site Operations Team, accountable for commercial product supply, NPIs, technology transfers, CDMO (tier 1 and/or tier 2) management, and strategyActive engagement of senior levels of management within Takeda and the CDMO, as needed. Acts independently or as a leader for a team.Acts as the Takeda Key Account Manager with CDMOs by serving as the primary point of contact. Such CMOs may have highly complex operations (manufacturing and packaging) and diverse product mixes (oncology, small molecule, and/or biologics).Lead tactical and strategic sourcing studies, and provide our Operating Unit with structured analyses and strong business cases to support site selection decisions Represent the voice of the CMO''s in internal discussions. Lead cross-functional External Supply Team(s) (co-lead the Joint Operations Team with CDMO) to manage quality performance and end-to-end supply of Takeda products at the Contract Manufacturer(s). Develop and execute Business Continuity Planning and any resulting Remediation/Risk Mitigation Plan for respective Contract Manufacturer(s). Develop both short-term and long-term plans with the Contract Manufacturer(s) and develop business cases to support and monitor execution through the Continuous Improvement Master Plan. Working with the External Supply Team(s), responsible for the proactive identification of continuous improvement opportunities (inclusive of cost reduction initiatives) In partnership with Finance, responsible for creation and execution of approved standard cost budget for Contract Manufacturer(s) spend typically exceeding $20 million per year. Ensure compliant execution of the financial workflow through Takeda and CM systems. Represent the External Supply Team and CDMOs as a lead contributor to the respective Operating Unit and Technical Operations Product Teams for the development and implementation of sourcing strategies, and effective management of our CDMOs. Includes: Maintain awareness of potential new sourcing opportunities and identify strategic sourcing partners Maintain awareness of changing regulatory trends in the industry to ensure all members of the network meet or exceed cGMPs and Takeda Quality Standards Provide day-to-day oversight of CDMOs to ensure operations remain in compliance with supplier performance, Quality, and process capability metrics. Establish key metrics to measure supplier performance and review them on a regular basis. Provide support and oversight (if necessary) for product transfers, new product introductions, and resolution of manufacturing issues. Responsible for both internal and external visibility of Contract Manufacturer(s) performance Responsible for aligned and responsible communication of issues, including executive communication where required, through the designated communication and/or escalation channels. Ensure CMO alignment with Takeda''s GMS Supply Value Proposition and annual objectives Develop strong relationships with the CDMOs to enable transparent communication and strong partnerships between the teams. Lead meeting preparation and execution activities for Joint Steering Committee meetings, Business Review Meetings, and internal Operation Review Meetings (CDMO dependent) Responsible to perform annual Health Assessment / Voice of Customer surveys (internal and external) to monitor the health of the team relationships. Create an action plan and remediate challenges, as necessary. Technical/Functional (Line) Expertise In-depth understanding of small molecule manufacturing and packaging technology including materials, processes, and design. Understand the industry landscape including suppliers, CMOs, and industry trends. The role will also demand specialist knowledge of the defined area, internally and externally, and for the jobholder to be acknowledged as a source of reference or Subject Matter Expert (SME) for tactical and strategic partnering and support for the Head of the Operating Unit. The role holder will require superior knowledge of the commercial active pharmaceutical ingredient, drug product, manufacturing, packaging, and routine and laboratory testing globally. They must keep up to date with changes and developments within the global market, understand where current CMOs sit within marketplace and drive change to industry strategy at the supply base. Experience in pharmaceutical GMP manufacturing. Leadership Strategic management, and managing by influence: ability to lead teams and CDMOs through influence in lieu of direct reporting relationships. Ability to motivate and inspire the team to achieve outstanding results. Prioritize projects and initiatives to keep the team efficient and align with business needs. Decision-making and Autonomy The individual would be expected to be comfortable in making good decisions when the situation is ambiguous. Make decisions quickly to support an agile organization. Interaction Ability to maintain a balanced objective viewpoint across functions and internal/external entities. Ability to proactively address and remove perceived roadblocks to success. Appreciation of cultural diversity. Collaborate with internal and external stakeholders, build strong business relationships and meet stakeholders'' needs. Building healthy, collaborative partnerships with suppliers is key. Innovation The individual thinks strategically,, and uses their deep insight while still thinking broadly, to identify opportunities and develop solutions that impact beyond their role/function. Further, the individual thinks innovatively about the industry and develops plans and strategies to change the future of Takeda and impact the industry. Devote time to seek out innovative ideas, build relationships with external partners to explore new possibilities, and reward plexity Sound understanding of the total cost of acquisition. Must deal with complex problems which may adversely affect more than one Takeda product/supplier site and ultimately Takeda sales revenue. Must understand the marketplace and various Supply Chain related global governmental/federal regulations. Deal with a wide range of problems that require complex judgments and innovative solutions in order to meet the needs of both Takeda Product Teams and the external supplier. Skilled and experienced at handling complex external negotiations both with and on behalf of internal customers, including the ability to avoid and diffuse conflicts if they arise. Must deal with complex problems which may adversely affect more than one Takeda product/supplier site and ultimately Takeda sales revenue. Must understand the marketplace and various Supply Chain related global governmental/federal regulations. Ability to thrive in a complex environment supporting many products, technologies, CMO''s, Suppliers, and stakeholders. What you bring to Takeda:REQUIRED EXPERIENCE: Bachelor''s degree required12+ years of pharmaceutical/biotechnology experience in at least two of the following cross-functional areas: manufacturing, supply chain, engineering, product development, project management, quality, or procurement. Strong understanding of cGMP. Solid background in production, supply chain, and regulatory requirements. Experience in the utility of outsourced goods and service providers. Held a position in which the ability to influence senior executives was demonstrated, as well as sound creative skills to utilize both traditional and innovative solutions. Must have a thorough knowledge of all aspects of product commercialization including product development, manufacturing, project management, supply chain management, operations, outsourcing, and post-commercialization technical support. Must have experience managing teams for high performance. Must be able to present ideas with clarity, conviction, and confidence. Must have a strong network among industry outsourcing/technical/business leaders. Willingness to travel to various meetings and/or CDMOs'' sites, including overnight trips. International travel may be required. Requires approximately 25% travel. DESIRED EXPERIENCE: Experience in two or more of the following areas: engineering, operations/production manager or materials manager, pharmacist/scientist. 5+ years of experience related to international operations and/or supply chain experience. Knowledge - comprehensive understanding of the pharmaceutical industry or related processes from a manufacturing environment in a large multi-national prescription drug manufacturer or related organization. Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner internally and externally. Strategic Implementation - ability to implement and monitor the overall supply chain strategy with thorough knowledge of the company''s operations, procurement expertise, industry knowledge, and competitive analysis. Management - leadership, project planning, status tracking, conflict resolution, building high-performing teams, and partnering with other departments and across cultures. People Development - ability to assess strengths and weaknesses of team/staff members and provide suggestions for improvement and opportunities to mentor staff. Analytical Skills - Ability to analyze a wide variety of data including product data, freight, forecasted sales, historical demand, in-transit, and potential stock-out figures to make daily management and production decisions. Supplier Relationship Management - builds mutually beneficial relationships between the company and third-party vendors, and fosters strong rapport with local and global partners to maintain a highly reliable supply chain and high level of customer service. Takeda Operations - A comprehensive understanding of Takeda''s operations. What Takeda can offer you:Comprehensive Healthcare: Medical, Dental, and VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs and company match charitable contributionsFamily Planning SupportProfessional training and development opportunitiesTuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This posting excludes Colorado applicants.GMSGQZR1LI-MA1EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Created: 2025-10-04