Shire Sr Tech Development Research Specialist in Social Circle, Georgia
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.
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Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.