Posted to MedZilla on 11/12/2019


Takeda Pharmaceuticals

US-MA, Senior Downstream Engineer II SR0038755-MZ


 
 

OBJECTIVES/PURPOSE

  • Member of the global team of process science experts responsible for the manufacturing process for Takeda s large and diverse commercial biologics portfolio
  • Acts as a senior subject matter expert across the biologics portfolio
  • Provides technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products

SCOPE

ACCOUNTABILITIES

  • Provide upstream and downstream technical expertise and leadership for various projects across the biologics portfolio, including: lifecycle initiatives to enable supply continuity, risk management, line extensions & discontinuation, process tech transfers, global expansion/contraction, COGs management, regulatory activities, and capability & improvement.
  • Ensure technical continuity of manufacturing processes across sites and time
  • Provide technical expertise for initiatives and investigations which are complex or span across multiple products
  • Lead process improvement projects that span sites or products
  • Ensure alignment of CMC content for multi-site products
  • Provide technical expertise required to maintain control strategy documents

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Has a good understanding of biologics manufacturing, the regulatory environment, life cycle management, and trends in innovation

Leadership

  • Ability to influence within teams 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

  • Represents Bio Process Sciences on various teams and is empowered to work within the team to align on decisions

Interaction

  • Provides feedback within Bio Process Sciences to ensure LCM alignment across products
  • Works with site MS teams on process improvement projects and other LCM projects
  • Works within product governance teams to align on effective product LCM
  • Works with Biologics Process Development on process improvements and other LCM projects

Innovation

  • Provides technical input to Biologics Process Development for process improvement and other LCM projects
  • Ensures process knowledge sharing across sites to ensure technical continuity for multi-site products

Complexity

  • Provides leadership on cross-funtional teams
  • Provides leadership to drive highly complex projects including ones that span multiple sites and products

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education / Experience

  • BS in engineering, life sciences, or related field with a Minimum 10 years experience, MS with a minimum of 8 years experience, or PhD with 0-5 years experience in pharmaceutical development and manufacturing
  • Experience operating globally in a matrix organization highly preferred

Skills

  • Must have technical knowledge and experience in upstream or downstream produces development
  • Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.

Behaviors

  • Focusing on the few priorities and provide superior results
  • Elevating capabilities for now and the future
  • Provide leadership on cross-functional teams

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.


Please visit our website at takedajobs.com

 
 


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