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Director Global Process Engineering Biologics

Lexington, Massachusetts, Zurich, Switzerland

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Director Global Process Engineering Biologics

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Job ID SR0039011 Date posted 07/08/2020 Location Lexington, Massachusetts; Zurich, Switzerland

OBJECTIVES/PURPOSE

Provide specialist process engineering expertise to ensure reliable, cost-effective, and standard technical solutions to manufacturing plants.

ACCOUNTABILITIES

  • Own and develop manufacturing process design and selection criteria to support all capital investments with specific emphasis on design, standards, and cost.
  • Lead evaluation of existing manufacturing processes and provide expertise on how to improve yield and efficiency while maintaining acceptable quality.
  • Deliver technology solutions designed for reliable operations, in line with throughput, OEE, and product quality.
  • Lead relevant site process engineers to evaluate the need for process standards understanding, network usage, business case, compliance, and complexity of implementation.
  • Drive and lead subject matter experts through working groups to deliver technology strategy, commonality in solution selection, standards, and troubleshooting.
  • Establish efficient, constant, and collaborative communication with the process engineering community to understand the Site needs, the best practices, and the installed standards, including the rationales and local specifics.
  • Develop & nurture core competencies of the process SMEs at sites to ensure technical capabilities are built and that knowledge and experience are maintained.
  • Be aware of technology process trends and benchmarks in the industry. Benchmark against peers so that Takeda is in-line with industry.
  • Ensure compliance to all regulatory GMP, Safety and Environmental requirements.
  • To be recognized as an SME across multiple sites.
  • Manage contractors and external vendors to deliver robust technical solutions.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Must be able to display in-depth knowledge and expertise in Biologics process engineering including such technologies as Upstream Cell Culture, Down Stream Purification, Filling & Packaging, as well as Cell Therapy Technology.
  • Displays strong problem-solving capabilities.
  • Can display analytical and conceptual thinking
  • Has a deep and broad understanding of pharmaceutical manufacturing process, regulatory environment, trends in process innovation, and financial acumen

Leadership

  • An enterprise leader balancing and aligning goals and priorities to meet company objectives
  • Ability to influence within the organization to drive decisions, alignment, and conflict resolution for complex cross-functional issues
  • Being a mentor developing future leaders
  • Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality into the organization

Decision-making and Autonomy

  • Full accountability for complex decisions regarding process engineering solutions, organization capability, and delivery of value to the business.

Interaction

  • Is able to easily engage with both internal and external stakeholders to drive performance and rollout process engineering solutions.
  • Collaborate across all technologies, including Plasma, Biologics, API, and Small Molecule within GMS to align on possible process standards like CIP and COP equipment.
  • Works across Site teams to align and implement process engineering best practices.

Innovation

  • Is capable of identifying the latest trends in the industry like an automated inspection for a complex portfolio.
  • Is able to benchmark against peers in the industry
  • Provides inputs for defining the innovation roadmap in GMS process engineering strategies
  • Ensures process knowledge sharing across sites and GE functions for effective development of organizational capabilities.

Complexity

  • Manages with a matrix of reporting lines and across functional areas
  • Provides leadership to drive highly complex process solutions that span multiple sites across different demographics.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Required

  • Degree in engineering (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent (mechanical / process / chemical or equivalent
  • Languages: Business fluent proficiency in English & Local Language (written and verbal),
  • Experience: More than 12 years of experience in GMP manufacturing relevant to the specialist area of expertise.
  • Minimum of 8 years of leadership experience
  • Broad knowledge of Biologics process solutions and best practice in the field of expertise.
  • High communication skills, analytical mindset, ability to work under pressure
  • GxP/QA knowledge
  • Innovative thinking
  • Building relationships and teamwork
  • Used to working in a complex global / matrix organization.
  • Can establish and coordinate service contracts with external service providers

Additional Desired Skills:

  • Experience with data analysis
  • Good understanding of the pharmaceutical industry not limited to technical aspects only

Travel requirements

  • Regular travels to Takeda sites within the region and to equipment and service providers. (Approx 25% travel)

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 SR0039011

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