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Senior Research Engineer-Cell CultureNew Jersey
Job Description:

Senior Research Engineer-Cell Culture Process Development

Responsibilities

Senior Research Engineer - Cell Culture Process Development group is responsible for leading projects supporting the development and optimization of mammalian cell culture processes for recombinant therapeutic proteins utilizing small-scale bioreactor models.  This includes process control strategy development, process scale-up and technology transfer to pilot plant and/or manufacturing sites.   Responsibility for supporting regulatory filings, leading/supporting organizational strategic initiatives, evaluating and/or installing new capabilities/technologies and leveraging internal and external influence to solve problems and benchmark potential solutions.

 

Lead the design, execution and interpretation of cell culture process development experiments to drive the definition and optimization of upstream processes for the generation of recombinant protein active pharmaceutical ingredients.

Use first principles and design of experiments (DoE) to predict/understand/control the impact of cell culture process parameters on recombinant protein product quality utilizing small-scale bioreactor models.

Support transfer of upstream processes to TS/MS labs as well as pilot plant and/or manufacturing sites.

Coach, train and lead others in the design, execution and interpretation of experiments to drive the definition and optimization of production processes

Keep abreast of relevant scientific literature, new technologies and regulatory requirements. 

Support regulatory filings (e.g. Information Requests, Pre-Approval Inspections, etc.)

 

Requirements:

Ph.D. in Chemical/Biochemical Engineering or Bioengineering

Minimum of 3-5 years of industrial experience in optimization and bioreactor scale-up of mammalian cell culture processes for production of therapeutic recombinant proteins

General knowledge of mammalian cell culture, molecular biology and fermentation with an emphasis on recombinant protein expression.

Effective oral and written communication as well as strong interpersonal skills is required.

General knowledge and understanding of challenges associated with scale-up and technology transfer of upstream processes as well as the use of statistical tools for data analysis.

Demonstrated problem solving and decision-making skills.

Demonstration of scientific and people leadership skills.

Must be able to work productively in an interdisciplinary team environment.

 

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