Scientist, Engineering

Merck Merck · Pharma · NJ

Scientist/engineer in Bioprocess Drug Substance and Commercialization group focusing on late-stage process development, technology transfer, and in-line support of biologics. Responsibilities include hands-on execution of downstream processing experiments, collaboration with commercial manufacturing, and authoring technical documents for licensure.

What you'd actually do

  1. Leading the hands-on execution of experiments in biologics downstream processing, including lab-scale process characterization, pilot-scale process development, and process scale-up/scale-down model development
  2. Collaborating with commercial manufacturing teams as a process sciences representative to support facility start-up and in-line support activities, including on-the-floor support for drug substance manufacturing as needed
  3. Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure

Skills

Required

  • Bachelor’s Degree or higher in Chemical Engineering, Chemistry, Biology or comparable discipline with 2+ years of experience
  • Significant experience with downstream processing of monoclonal antibody (mAb) products or similar products in a laboratory or manufacturing setting, including unit operations such as membrane filtration, preparative chromatography, ultrafiltration or tangential flow filtration, and viral clearance unit operations
  • Mechanistic understanding of downstream processing separation sciences
  • Ability to understand and execute experiments independently in a manner that meets quality and timeline expectations
  • Well-developed communication, organizational, and problem-solving skills, with an attention to detail
  • Clinical Manufacturing
  • Data Analysis
  • Detail-Oriented
  • Downstream Process Development
  • Experimentation
  • Good Manufacturing Practices (GMP)
  • Interdisciplinary Collaboration
  • Technical Writing
  • Technology Transfer
  • Writing Technical Documents

Nice to have

  • Large molecule drug substance technology transfer
  • Collaboration with analytical teams, pilot-scale, and/or manufacturing environment
  • Experience authoring technical documentation in support of the following: process description, process characterization, process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.
  • Current Good Manufacturing Practice (cGMP) awareness or experience