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Associate Director Cell Therapy Operations

Lexington, Massachusetts

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Associate Director Cell Therapy Operations

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Job ID SR0052811 Date posted 09/01/2020 Location Lexington, Massachusetts

Primary Duties

The Associate Director of Cell Therapy Operations is responsible for the leadership and overall management of the commercial manufacturing operation.  The key deliverable, and capabilities within this function include:

  • Team leadership and people development
  • Ensures successful execution of cell therapy processes in an GMP environment
  • Continuous improvement and collaboration with internal and external partners to ensure best in class operation

The Associate Director partners with CTTE (Cell Therapy Translational Engine), Quality, Facilities, Engineering, Validation, Supply Chain, Process Development, and Regulatory Affairs to provide commercial and clinical product support of drug substance to internal GMP manufacturing sites. The Associate Director is responsible for driving the organization towards a culture of innovation, collaboration, best practice, accountability, and efficiency.  The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved.

Responsibilities:

40% of Time: 

Manage Staff - Through direct supervision and in terms of project coordination, resource allocation, budget control, and methodologies.

  • Lead a team that will consist of people leaders and individual contributors responsible for manufacturing cell therapy programs from thaw to finished drug product.
  • Motivate and support the career development and technical expertise of reports, and communicate company policies/goals/strategies/business results.
  • Work closely with cross-site and interdepartmental leadership to meet functional and company goals.
  • Engages in proactive measure to promote and foster a positive safety culture.
  • Champion self-initiated projects and drive area under their control within the context of corporate and functional area priorities; justify goals to senior management.
  • Attract and retain key talent in the organization.
  • Foster teamwork and drive project/process improvements.
  • Expected to lead cross-functional projects and teams.
  • Develop of culture of learning through use of Human Performance methodology and practice.

20% of Time: 

Process Improvement/Change and Project Management – Provide leadership in solution implementation.

  • Work with various functions to develop solutions and champion the implementation in manufacturing.
  • Support developing data packages with rationales for changes or improvements in production processes.
  • Specify requirements to manufacturing instructions for changes to the manufacturing processes and associated systems
  • Assist in authoring electronic documents including SOPs and batch records
  • Providing training for technical staff on major changes to processes, equipment and documentation

40 % of Time: 

Technical SME – Provide engineering and scientific solutions to improve site knowledge in Cell Therapy.

  • Assist in design of a new state of the art facility and ensure operational success.  This will include building an MES (Manufacturing Execution Systems) platform, operating a paperless facility and optimizing a new organizational structure.
  • Facilitate technical troubleshooting when necessary and participate in investigations.
  • Build and create new work processes that take full advantage of the level of integration and automation that will exist in the new facility.
  • Partner with quality to ensure systems such as training focus on both compliance and efficient knowledge acquisition.
  • Utilize new technology to drive solutions throughout the site.

Education and Experience Requirements

  • BS Degree in Science or Engineering with 10+ years of relevant experiences.
  • Proven record of technical leadership, including ability to influence, motivate, and drive technical rigor.
  • Proven record of people management, including the ability to manage multiple priorities, maximize staff effectiveness, and allocate resources in a dynamic environment.
  • Significant knowledge of cGMP and regulatory requirements related to manufacturing of biologic products.
  • Previous cell therapy experience is preferred, but not required.

Key Skills, Abilities, and Competencies

  • Proven record of technical and strategic leadership, including ability to influence, motivate, and drive technical rigor.
  • Skill in performance management of technical professionals which includes goal setting, reviews, career, talent and professional development of team.
  • Ability to provide direction and leadership as well as work load planning, organization and coordination for team. Proven troubleshooting, problem solving and investigation skills.
  • Skill in measurement, analysis, and continuous improvement of processes and organizations
  • Initiates and maintains extensive contacts with representatives of other organizations

Excellent communication, technical, organizational, leadership, and mentoring skills are required. Must be a team player prepared to lead, work in, and embrace a team-based culture

Complexity and Problem Solving

  • Ability to makes decisions that could involve multiple courses of action that evolve over time based on changing business need / priority.
  • Is a member of the leadership team and recipient of escalation communications from within the business. As such, appropriately responds to incoming information to remove roadblocks, provide guidance, and hold individuals/ teams accountable for achieving results.
  • Technical decisions on investigations, continuous improvement initiatives, and schedule optimizations.  

Internal and External Contacts

  • Manufacturing
  • Engineering
  • Process Development
  • Cell Therapy Translational Engine
  • Supply Chain
  • Quality
  • Facilities
  • Regulatory
  • External

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0052811

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