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CMC Lead-Cell Therapy (Director level)

Company: Takeda Pharmaceuticals International GmbH
Location: Lexington
Posted on: February 22, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info. Every day, employees working in Takeda's Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients. Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference. Success What makes a successful member of our team? Check out the traits we're looking for and see if you have the right mix. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a CMC Lead, (Director level) for our newer cell therapy products in one of our Boston, MA location or Zurich, Switzerland. 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. ACCOUNTABILITIES

  • Responsible for CMC strategy to enable effective lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product and process knowledge, capability & improvement, tech transfer, and process validation
  • Aligns with TOPT on CMC LMC strategy
  • Drives the link between CMC strategy on the TOPT team and CMC execution on the CMC subteam
  • Is the overall product and process expert for the product; provides bridges across expertise represented on the CMC team
  • Accountable to provide yield tracking and projections
  • Accountable for ensuring harmonization and knowledge sharing between facilities
  • Accountable for CMC sections of product dossiers
  • Provide SME expertise in major process and methods investigations.
  • Assess and provide feedback to cross-functional technical proposals and recommendations.
  • Manage multiple workstreams and projects. Make sound and timely decisions based on project priorities. Discern paths forward within ambiguous environments. DIMENSIONS AND ASPECTS
    • Has a deep and broad understanding of cell therapy/biologics manufacturing, the regulatory environment, life cycle management, trends in innovation, and financial acumen
    • Provides effective CMC leadership for product management
    • Ability to influence broadly across the organization to drive decisions, alignment, and conflict resolution for complex cross-functional CMC
    • Being a coach and mentor for CMC team members that may require more guidance
    • Provides vision and passion for driving technology and innovation within the biologics portfolio
    • Able to operate effectively through ambiguity
    • Is able to effectively manage multiple products
    • Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality into the organization
    • Is essentially autonomous requiring little supervisory guidance on CMC LCM for the products they cover
    • Has overall decision authority for activities managed by the CMC subteam
    • Works across GMSci Bio/cell therapy to align CMC LCM activities with the Head of Biologics Process Sciences and the Head of Biologics Product Sciences
    • Works across GMSci global functions as needed for business metrics and align on LCM procedures
    • Works across GMSci Bio, Pharmaceutical Sciences, and Site Manufacturing Sciences groups to align on vision and priorities for Biologics and Cell Therapy LCM and Technology Excellence.
    • Works with the Pharmaceutical LCM group on coordination of hand-off of late-stage products to the commercial team
    • Uses an innovative approach to solving complex CMC LCM issues
    • Draws in others focused on innovation to drive better outcomes from the product.
    • Manages with a matrix of reporting lines and across functional areas
    • Provides leadership to drive highly complex projects involving cutting across multiple sites and products EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Education / experience
      • Degree in engineering or life sciences
      • Minimum 12 years experience in pharmaceutical development and manufacturing; PhD highly preferred
      • Experience with Cell Therapy products is required.
      • Experience operating globally in a matrixed organization highly preferred
      • Experience defining the strategy and roadmap for complex, cross-functional CMC initiatives Skills
        • Must be self-motivated, have good interpersonal and communication skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools. Behaviours
          • Strategic enterprise thinking, finding innovative ways to serve patients, building a reputation, and trust
          • Creating an environment that inspires and enables people
          • Focusing on the few priorities and provide superior results
          • Elevating capabilities for now and the future Check out where you could be
            working if you apply. Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Huntsville , CMC Lead-Cell Therapy (Director level), Executive , Lexington, Alabama

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