Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior External Site Leader in our Lexington, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
Ensure the uninterrupted supply of drug product and finished goods from external suppliers which meet all quality requirements to support the small molecule market demands in the region and countries being supplied from suppliers in the region. Develop regional supply chain strategies, manage supplier metrics and projects in the region. This will be accomplished through planning and on-time execution of 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 product 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 product and finished goods.
- 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, NPI s, technology transfers, CDMO management and strategy.
- Acts independently or as a leader for a team of Takeda Key Account Manager with CDMO s by serving as the primary point of contact.
- 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 the cross-functional External Site Operations Team (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 Site Operations Team, responsible for 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. Ensure compliant execution of the financial workflow through Takeda and CM systems
- Represent the External Site Operations Team and CDMOs as a lead contributor to the respective Operating Unit and Technical Operations Product Teams for 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 member 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, SQI and process capability metrics. Establish key metrics to measure supplier performance and review on a egular 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 to Contract Manufacturer(s) performance
- Responsible for aligned and responsible communication of issue, 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 health of the team relationships. Create action plan and remediate challenges as necessary
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- 12+ years pharmaceutical/biotechnology experience in at least two of the following cross-functional areas: manufacturing, supply chain, engineering, product development, project management, quality or procurement
- 5+ years experience related to international operations and/or supply chain
- Strong understanding of cGMP
- Solid background in production, supply chain and regulatory requirements.
- Experience in 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 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.
- Experience in two or more of the following areas: engineering, operations/production manager or materials manager, pharmacist/scientist.
- 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 through knowledge of 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 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 company and third party vendors, fosters strong rapport with local and global partners to maintain a highly reliable supply chain and high level of customer service
- Takeda Operations comprehensive understanding of Takeda s operations.
- Willingness to travel to various meetings or client sites, including overnight trips. International travel may be required.
- Requires approximately 25% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.