Associate Director, Vaccine Raw Materials & Components - Vaccine Business Unit
Location:
Cambridge , Massachusetts
Posted:
February 24, 2018
Reference:
1703371

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Vaccine Raw Materials & Components in our Cambridge, Massachusetts office.

H ere, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Vaccine Raw Materials & Components working on the Vaccine Operations team, you will be empowered to make meaningful contribution, and a typical day will include:

POSITION OBJECTIVES:
  • Develop and execute the supply strategy for raw materials and components used in externally manufactured vaccines.
  • Provide technical leadership 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.
  • Build and manage relationships with third party suppliers of key RMCs, working closely with internal (Procurement, Finance) and external stakeholders
  • Identify and implement continuous improvement opportunities in use and management of RMCs across the external network.


POSITION ACCOUNTABILITIES:
  • Lead a cross-functional team with membership from Procurement, Quality, Supply Chain and other functions to develop the strategy for robust and reliable supply and performance of critical RMCs.
  • Provide subject matter expertise for the development of robust tech transfer and validation plans, and ensure both internal and external alignment around ongoing RMC usage and supply requirements.
  • Develop and manage relationships with key RMC suppliers. Track and manage performance. Track project performance and timelines. Lead efforts to address any potential supply risks, working closely with cross-functional partners.
  • Provide input to negotiation of supply agreements. 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 related regulatory submission sections. Manage vendor change notifications.
  • Provide subject matter expertise for the development of technical transfer plans and overall manufacturing strategies, as well as input to product teams in regards to RMC selection, usage, and lifecycle management.
  • Identify and implement improvements in vaccine operations to improve process performance, manufacturing cost/efficiency and/or operations quality performance, specifically regarding RMC supply. Track associated budgets.
  • 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.
  • Build and manage a team to drive the above activities. Oversee deliverables as outlined above. Set objectives and manage activities according to plan. Establish and track development plans.
  • While the focus of this position is external manufacturing, alignment with Takeda Global. Manufacturing and Supply operations and with internal manufacturing operations, as it relates to RMCs, will be required.







Qualifications:


EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:

  • B.S. with at least 10-15 years or M.S. with at least 8 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.
  • Strong leadership skills, with ability to lead and manage a team, serve as a partner, and influence others in a highly cross-functional and dynamic environment. Requires good presentation and communications skills.
  • Ability to work effectively on multiple project teams and initiatives happening in parallel. The candidate must be self-motivated, able to prioritize and manage, and meet project deadlines and budgets.
  • 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 a strong plus.


TRAVEL REQUIREMENTS:
  • 30-40%


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

Learn more at takedajobs.com .



Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

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