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Assoc. Scientist – Engineering

Assoc. Scientist – Engineering

CompanyMerck
LocationNorth Wales, PA, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s
Experience LevelEntry Level/New Grad, Junior

Requirements

  • BS (or expected completion within 6 months of application) in Chemical/Biochemical/Biomedical Engineering, Biotechnology, Biochemistry, Microbiology, Structural biology, or related fields
  • Relevant academic, internship, co-op, or professional experience in a laboratory setting.
  • Excellent oral and written communication skills
  • Well-developed organizational, record-keeping, and problem-solving skills, with an attention to detail.

Responsibilities

  • Executing process development in vaccine downstream processing including lab-scale process development and optimization, in-process assay support, and process scale-up/scale-down model development.
  • Supporting the hands-on execution of lab-scale experiments and authoring associated technical reports and documents.
  • Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing.
  • Supporting assignment execution against accelerated, critical-path timelines in a right-first-time manner.
  • Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
  • Participate in and drive organizational excellence practices such as technical standards, process platforms, operational procedures.

Preferred Qualifications

  • Hands-on expertise with downstream unit operations (i.e. membrane filtration, chromatography, etc.) and process development for large molecules
  • Ability to understand and execute experiments independently in fulfillment of assigned program objectives in a manner that meets quality and timeline expectations
  • Experience within or collaboration with analytical teams, pilot-scale, and/or manufacturing environment
  • Large molecule drug substance process development, scaling (up and down) and technology transfer
  • Current Good Manufacturing Practice (cGMP) awareness or experience
  • Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions
  • Communication of scientific information through oral presentations and written documents