Thermo Fisher Scientific-posted about 1 year ago
Full-time • Mid Level
Plainville, MA
10,001+ employees
Computer and Electronic Product Manufacturing

The Upstream or Downstream Process Development Scientist II at Thermo Fisher Scientific plays a crucial role in supporting the development and transfer of processes for viral vector production, contributing to life-saving therapies. This position involves planning, executing, and detailing laboratory activities, acting as a subject matter expert, and ensuring a seamless transition of processes into cGMP manufacturing.

  • Contribute to process development and scale-up projects.
  • Act as a subject matter expert in upstream or downstream processes for viral vectors.
  • Lead training activities.
  • Prepare and modify development documents and reports.
  • Identify technical challenges and solutions for new processes.
  • Support analytical testing and data interpretation.
  • B.S. in Chemical Engineering, Biochemistry, Biology or related field with 3+ years of experience or a Master's degree.
  • Proven understanding of experimental design and the ability to independently conduct laboratory experiments.
  • Collaborate with the Analytical Development team to develop comprehensive testing plans.
  • Participate in client meetings to present results and assist with drafting process development reports.
  • Independently prepare or review Process Development records, work instructions, and batch records.
  • Design and conduct Design of Experiments (DOE) studies and high-throughput screenings tailored for either upstream or downstream process development.
  • Proficiency in technical writing, adhering to Good Documentation Practices (GDP), with preferred experience in data compilation and interpretation.
  • Strong communication skills with the ability to clearly and concisely interpret, summarize, and present scientific data.
  • Practical experience in aseptic techniques, cell culture, single-use bioreactors (SUBs), wave reactors, and harvest/clarification processes.
  • Familiarity with transfection and infection-based processes for gene therapy production.
  • Expertise in working with single-use stirred tank bioreactors.
  • Experience in scaling up and scaling down upstream processes for viral vectors or biologics.
  • Expertise in various purification techniques, including affinity and anion exchange chromatography, with proficiency in using AKTA chromatography systems and Unicorn software.
  • Extensive experience with filtration-based unit operations such as tangential flow filtration, sterile filtration, and depth filtration.
  • Competitive remuneration
  • Annual incentive plan bonus
  • Healthcare
  • Range of employee benefits
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