The Manager, External Supply Project Management will:
Execute the supply strategy for raw materials and components used for externally manufactured vaccines.
Provide technical assessments and recommendations for all RMC management activities, liaising with Quality, Regulatory, and other internal stakeholders.
Lead RMC related projects to timely execution in order to support clinical and commercial vaccines programs
- Maintain good working relationships with third party suppliers of key RMCs, working closely with internal (Procurement, Finance) and external stakeholders
Participate in cross-functional teams with membership from Procurement, Quality, Supply Chain and other functions to ensure robust and reliable supply of critical RMCs.
Provide subject matter expertise for the development of robust tech transfer and validation plans, and align with internal and external stakeholders around ongoing RMC usage and supply requirements.
Manage relationships with key RMC suppliers. Track project performance and timelines. Address any potential supply risks, working closely with cross-functional partners.
Manage Purchase Orders for work with RMC suppliers. Manage requests for samples needed to be shipped to or from suppliers for development or trial purposes.
Write technical assessments and develop risk assessments to support qualification activities, deviation closure, CAPA and the change control process. Provide input to related regulatory submission sections. Manage vendor change notifications.
Provide subject matter expertise for the development of technical transfer plans and input to product teams in regard to RMC selection, usage, and lifecycle management.
Support third party manufacturers to develop Raw Materials Risk assessments and ensure robust plans are in place to for supply of RMCs which are procured by third parties but consumed in Takeda products.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
B.S. with at least 3-5 years or M.S. with at least 2 years of experience in bio- pharmaceutical manufacturing. A degree in biochemical engineering, biotechnology or a related discipline is highly preferred.
Specific experience in raw materials and components management and familiarity with related manufacturing and quality systems. Focus areas may include single-use components and complex animal-derived raw materials.
Knowledge of cGMPs and regulatory guidance relevant to management of raw materials and components, from process development through formulation, filling, and finishing of parenteral products.
Experience working directly with third parties and proven ability to develop and manage alliance partner negotiations and relationships.
Ability to work in a highly cross-functional and dynamic environment. Requires good communications skills.
Ability to work effectively on multiple project teams and initiatives happening in parallel. The candidate must be self-motivated and able to prioritize and manage.
Technical writing skills and capability to clearly articulate changes, risks, and impact assessments. Experience with audit inspections and the preparation of responses to regulatory submission questions from agencies
Familiarity with SAP and materials documentation / consumption planning is an advantage.
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