Quality Control Method Support - Associate Director

Company: Takeda Pharmaceuticals International GmbH
Location: Lexington
Posted on: April 8, 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. Quality Control Method Support - Associate Director 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. Quality Control Method Support - Associate Director Job ID R0030097 Date posted 02/24/2021 Location Lexington, Massachusetts 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 Description Primary Duties Direct the Quality Control Method Support function which is responsible for overseeing method transfer, validation, and method lifecycle support at the MA Biologics Operations (MA Bio Ops) quality laboratories. Technical areas supported include Analytical (HPLC, UPLC, CE), Biochemistry, Cell Biology, Raw Materials, and Microbiology disciplines. The laboratories are accountable for the on-time delivery of data in support of in-process, release and stability activities. The individual will drive accountability to deliver to targets for commercial and clinical method introduction and remediation of defined site-based and external programs, engage with peers across the MA Bio Ops site (and larger external network, as needed) to influence method selection and filing strategy, and collaborate on continuous improvement (Cl) activities. This leader will ensure that new method introduction and support is performed with a customer focus that includes consideration for reliability, sustainability, data integrity and general GMP-compliance. Direct resources to support daily operations of the laboratories such as critical reagent supply and overall method trending/performance. In addition, the introduction of new technology to improve sustainability and compliance is expected. The role requires direct management of individuals, including goal setting, performance feedback, skills development, and mentoring. Job Summary/Operations Involvement:

• Responsible for the successful operation of method introduction and support activities of major significance to the organization.
• May become involved in daily operational activities to drive improvement and accountability.
• Ensures that overall budgets, schedules, and performance standards are realistically set and attained.
• Erroneous decisions will result in critical delays in schedules and / or unit operations and may jeopardize overall business activities. Impact:
  • Exerts influence in the development of overall objectives and long-range goals of the organization.
  • Erroneous decisions or recommendations would normally result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity. Responsibilities
    • 25% of time: Mentoring, development of team skills
    • 50% of time: Method validation & lifecycle support
    • 25% of time: Regulatory-related support (APQR, CMC, etc) Education and Experience Requirements
      • Minimum of B.S. in a scientific discipline
      • 15+ year's experience in a biopharmaceutical laboratory setting Demonstrated knowledge and experience with method transfer and validation Key Skills, Abilities, and Competencies
        • Technical experience in biopharmaceutical laboratory techniques, as well a broader understanding of method principles outside of immediate experience
        • Demonstrated ability to solve problems, drive improvement, and develop plans and advance to completion on time and in full.
        • Diverse technical understanding and ability to apply skills/knowledge to new technology
        • Extensive method validation experience per ICH requirements
        • Troubleshooting and root cause analysis skills
        • Leadership and mentoring of individual contributors
        • Use of common Microsoft Office tools
        • Statistical or other analysis software Complexity and Problem Solving
          • Solve routine problems of moderate to significant scope and complexity following established policies and procedures.
          • Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
          • Builds stable working relationships internally. Internal and External Contacts
            • The role is directly accountable to the MABioOps Director of QC Operations
            • Key internal partners include the personnel in the HPLC, Biochemistry, Cell Biology, Microbiology and Raw Materials groups in Lexington, Assay Development teams, and personnel in the broader site and global Quality Control organization. Additional partners include the Project Management Office and broader site Quality management.
            • External: interacting with vendors as needed, and regulatory agencies. Other Job Requirements The following physical abilities are required in order to fulfill the job duties:
              • Ability to work around chemicals as an observer only. The role is not expected to perform actual lab operations.
              • Ability to wear basic personal protective equipment such as gloves, gowning, and eye protection while in laboratory areas .
              • Ability to walk and stand for periods of time. 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 , Quality Control Method Support - Associate Director, Executive , Lexington, Alabama