Sr Scientist, RNA

AldevronFargo, ND
219d

About The Position

The Sr Scientist role is responsible for overseeing multiple new technical transfer activities involving Drug Substance and Drug Product program life cycles from development through clinical and commercial applications from both internal and external sending parties with a specialization in RNA Drug Substance. This position reports to the Manager of RNA Technical Operations and is part of the Technical Operations Department located in Fargo, ND and will be an on-site role. In this role, you will have the opportunity to design, execute and oversee new process unit operations and bring innovative ideas to troubleshoot problems. You will lead and facilitate the onboarding of technical transfers throughout the product life cycle and steer later phase application programs to meet clinical standards. Additionally, you will mentor other teammates in Tech Ops and other crossfunctional teams through training of innovative initiatives, optimizations, and unit operations. You will execute and lead change controls, quality event investigations, and support process qualification/validation initiatives. Furthermore, you will steer both internal and external parties as the subject matter expert (SME) providing technical support in a timely manner to drive on time delivery and right first time metrics.

Requirements

  • BS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 6+ years of experience.
  • MS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 3+ years of experience.
  • PhD in biology, molecular biology, biochemistry, chemistry, or related discipline with 3+ years of experience.
  • Experience in leading RNA technical transfer projects in a cGMP environment.
  • Ability to apply critical thinking and oversee multiple projects with robust knowledge of processes and procedures.

Nice To Haves

  • Working knowledge of current industry drug substance and drug product regulatory guidelines.

Responsibilities

  • Design, execute and oversee new process unit operations and troubleshoot problems.
  • Lead and facilitate the onboarding of technical transfers throughout the product life cycle.
  • Steer later phase application programs to meet clinical standards.
  • Mentor teammates in Tech Ops and crossfunctional teams.
  • Execute and lead change controls and quality event investigations.
  • Support process qualification/validation initiatives.
  • Provide technical support as a subject matter expert (SME) to internal and external parties.

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What This Job Offers

Career Level

Mid Level

Industry

Chemical Manufacturing

Education Level

Bachelor's degree

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