Posted to MedZilla on 3/18/2019

Takeda Pharmaceuticals

US-GA, Sr Tech Development Research Specialist SR0032935-MZ


Effectively contribute to manufacturing support via supporting deviation investigations and process robustness improvements, assisting quality and manufacturing partners in troubleshooting issues, supporting regulatory inspections and defending technical decisions to regulatory agencies, and supporting process validation maintenance. Display basic technical understanding of biochemical and technical aspects of biologics process. Conduct routine/non-routine research and design experiments with minimal assistance.

  • Provide training, advice and assistance to team members, manufacturing, and quality regarding analytical and process problems.
  • Make sound technical recommendations and contribute to technical feasibility analysis regarding projects/matters.
  • Independently plan and execute a series of design and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
  • Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.
  • Evaluate results relative to protocol requirements, definitions and/or study goals. Provide analytical interpretation of result from studies to stakeholders.
  • Adhere to quality system, understand and apply applicable corporate, divisional and departmental procedures. Knowledge of related regulations and guidance (e.g., USP,
  • CH, and regional compendia) to facilitate compliance.

  • Typically requires bachelors' degree in science, engineering or other related technical field. 4+ years of related experience.
  • The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills.
  • Research lab experience may include research in GMP environment, cross-functional teamwork, and independent experimentation in method development and validation.

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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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.