Posted to MedZilla on 9/18/2019

Takeda Pharmaceuticals

US-GA, Director, Manufacturing Sciences SR0036186-MZ


The position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Takeda additional capacity for production, purification, and fill and finish for its biologic medications. Recognized as leader within division. Primary focus is on ensuring project designs meet user requirements and comply with all Takeda expectations for safe and efficient operation, cGMP compliance, and technical process requirements. Maintains harmonization of design across multiple production modules at a site. Interfaces with validation, quality, and manufacturing to ensure efficient initial startup and ramp up to full capacity. Provides leadership in the development of new ideas, products, processes and techniques. Frequently manages an organization and a budget in excess of $5 million dollars. Directs through management team the completion of complex projects or programs within boundaries of quality, time and budget. Based on significant technical expertise, reviews and approves complex design concepts of technical staff. Provides technical direction to staff. Fosters an environment of creativity and innovation in completing divisional and cross-functional/business unit responsibilities.

  • Provides strategic planning leadership by setting strategies and priorities based upon anticipation and application of industry trends and emerging technologies.
  • Ensures that needed resources to support projects and operations are available by close partnering with senior leadership; defines, develops and leads site engineering organization.
  • Create and communicate global vision of the organizations contribution to the business unit/division goals, ensuring industry leadership.
  • Maximize the effectiveness of internal and external resources (business unit and cross-business unit) to meet business objectives.
  • Direct the development and implementation of new product/process requiring new technologies starting from Project Proposal through Post-Launch Quality Assessment.
  • Using broad knowledge and experience in cross-functional activities, coordinate and direct activities of teams and individual contributors to ensure market dominance in appropriate product lines.
  • Create and maintain an environment where team members experience personal and professional growth and become a more self-directed team.
  • Responsible for Final Approval on product/process documentation.
  • Review and approves proposals to determine if benefits derived and possible applications justify expenditures. Presents proposal to senior management for consideration and allocation of funds.
  • Provide strategic planning leadership to ensure adequate resources are available to complete all business unit and division responsibility.

Requires a bachelor's degree, preferably in science, engineering or other related technical field. 10+ years of related experience with 7+ in a management role.

  • Experience with Quality Systems and Processes preferably in a FDA regulated manufacturing setting.
  • Demonstrated understanding of business drivers, customer needs and multi-site dynamics to create viable strategic plans.
  • Ability to establish long-range business plans which anticipate global trends, technical, economic and socio-political conditions.
  • Demonstrate understanding of business drivers, customer needs and global dynamics to create viable strategic plans.
  • Proven track record of management/leadership effectiveness.
  • Must possess strong ability to negotiate and maximize effectiveness of resources and influence others internally and externally.

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.

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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.

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