Posted to MedZilla on 5/29/2017


Takeda Pharmaceuticals

US-MA, Engineer IV 1701256-MZ


 
 

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.
While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients lives. If you are driven to create better health and a brighter future, join us!

OBJECTIVES:

Responsible for providing technical leadership for commercial project implementation and coordination by independently planning and transferring unit operations/characterization and optimization efforts. Additionally this position assists with preparing technology transfer documentation and provides onsite support/trouble shooting during technology transfer or manufacturing CMOs as appropriate. This may include leading technology transfer activities and compiling vendor data for presentation. This position also independently interprets and communicates results and owns technical aspects of a project. This FTE will manage and prioritize tasks providing support to Contract Manufacturing, Quality, and Validation for deviation investigation, change controls, and CAPA. In addition , the Engineer will perform originator/author and EMR administration functions in documentation systems (Trackwise and Mosaic). Provide leadership and guidance to cross functional teams associated with change review. Attend and present at CMC,CCRB and MRB investigation meetings as required.

ACCOUNTABILITIES:

  • Works with departmental and/or cross functional peers to execute on assignments, under limited supervision.
  • Owns responsibility for technical aspects of a project
  • Prepares protocols and technical reports.
  • Contributes significantly to project work which may include multiple projects within functional area.
  • Reviews, interprets and communicates data ( to supervisor, project teams) and prepares associated technical reports.
  • Proposes and implements resolutions to technical problems/issues
  • Participate actively on project teams by communicating activities from designated functional area to project team
  • Assists with the development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
  • Supports local initiatives as directed and participates in global CMC or functional initiatives as appropriate.
  • Serves as a technical resource and leverages expertise in process technology as a functional resource (SME)
  • Coordinates within departmental as well as cross functionally with peers on project

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Required:
  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience,
  • Previous experience working in cGMP manufacturing setting
Knowledge and Skills:
  • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
  • Teamwork Ability to work well in a highly cross-functional team environment
  • Communication Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues ; timely and effectively communicates issues to supervisor; technical writing skills to support contributing to internal technical documents
  • Organization Exercises good time management and prioritization skills and is able to successfully manage multiple tasks simultaneously
  • Knowledge Sharing - Ability to capture organizational knowledge; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
  • Technical - Advanced proficiency in the understanding of GMP manufacturing equipment and operations

PHYSICAL DEMANDS:

  • As PIP, CMO PPE and gowning required for classified space as required
TRAVEL REQUIREMENTS:
  • May require approximately ~5% travel.

LINE FUNCTION SPECIFIC QUALIFICATIONS:
Biologics - Cell Culture: Statistical analysis techniques; Experience with cell culture and aseptic techniques; Experience laboratory equipment that supports cell culture, such as bioreactors, metabolite analyzers, shake flasks, cell culture plates; Familiar with large scale cell culture manufacturing; Experience with equipment automation and control.
Biologics - Purification: Solid understanding of chromatographic and other protein separation principles; Hands-on experience with the development and scale-up of purification processes and the use of bioseparation equipment; Knowledge of design of experiments principles and statistical analysis techniques; Experience with standard analytical assays
Biologics ADC: Solid understanding of bioconjugation principles; Experience with common conjugation chemistries; Knowledge of design of experiments principles and statistical analysis techniques; Handling of cytotoxic compounds required; Experience with standard bioconjugation assays

we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-KH1


Schedule


Please visit our website at takedajobs.com

 
 


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