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Downstream Process Development Scientist

Eurofins Medical Device Services US

Boston, MAOnsitePosted 1 day ago$32.00 - $36.00/hour
Full TimeEntry LevelManufacturing & CMC
Original posting ↗

Summary

Our Eurofins PSS team is seeking a Downstream Scientist to work onsite supporting our client's downstream process development activities related to the production of sterile, injectable lentiviral vector (LVV)-based gene therapy products. The successful candidate will help support purification process definition and optimization, process robustness studies, and process transfers to pilot plant and manufacturing sites, and authorship of downstream process development technical documentation. This role partners closely with cross-functional teams across the CMC project teams to support all upstream operations for the client's program.

Job description

Position Overview

Our Eurofins PSS team is seeking a Downstream Scientist to work onsite supporting our client's downstream process development activities related to the production of sterile, injectable lentiviral vector (LVV)-based gene therapy products. The successful candidate will help support purification process definition and optimization, process robustness studies, and process transfers to pilot plant and manufacturing sites, and authorship of downstream process development technical documentation. This role partners closely with cross-functional teams across the CMC project teams to support all upstream operations for the client's program.

Job Responsibilities

  • Support the execution of purification development and characterization experiments.
  • Collaborate with cross-functional teams to coordinate analytical testing, exchange materials, share technical observations, and align on project timelines.
  • Support transfer of purification processes to pilot plant and manufacturing sites.
  • Maintain lab stocks, supplies, and equipment specific to the downstream team to support daily operations.
  • Document process data in electronic lab notebook and shared databases and communicate key observations in team meetings.

Basic Minimum Qualifications

  • B.S. in Biology, Biochemistry, Biological Engineering or a related field with at least 1 year of relevant industry experience OR M.S. in Biology, Biochemistry, Biological Engineering or a related field with at least 6 months of relevant industry experience.
  • Hands-on experience following established downstream chromatography and filtration protocols, including ion exchange and affinity chromatography, TFF, and/or UF/DF methods.
  • Pragmatic problem solver with get-it-done attitude.
  • Experience documenting process results in electronic lab notebooks and effectively communicating experimental observations to management and cross-functional team.
  • Meticulous attention to detail in sample tracking, experiment execution, data recording, and laboratory documentation.
  • Ability to set priorities and multi-task activities to effectively manage workflows and drive deliverables to completion.
  • Strong team orientation, with excellent organizational skills, self-motivation, and a positive attitude.
  • Strong communication skills, with the ability to clearly communicate experimental results and observations.
  • Authorization to work in the United States indefinitely without restriction or sponsorship.

Preferred Qualifications

  • Hands-on experience with Cytiva AKTA liquid chromatography equipment (AKTA pure, AKTA avant).
  • Hands-on experience with end-to-end biologics purification process development, MSAT, or manufacturing; experience with viral vectors is a plus.
  • Experience with statistical design of experiments (DOE) software.

Requirements

  • B.S. in Biology, Biochemistry, Biological Engineering or a related field with at least 1 year of relevant industry experience OR M.S. in Biology, Biochemistry, Biological Engineering or a related field with at least 6 months of relevant industry experience
  • Hands-on experience following established downstream chromatography and filtration protocols, including ion exchange and affinity chromatography, TFF, and/or UF/DF methods
  • Pragmatic problem solver with get-it-done attitude
  • Experience documenting process results in electronic lab notebooks and effectively communicating experimental observations to management and cross-functional team
  • Meticulous attention to detail in sample tracking, experiment execution, data recording, and laboratory documentation
  • Ability to set priorities and multi-task activities to effectively manage workflows and drive deliverables to completion
  • Strong team orientation, with excellent organizational skills, self-motivation, and a positive attitude
  • Strong communication skills, with the ability to clearly communicate experimental results and observations
  • Authorization to work in the United States indefinitely without restriction or sponsorship
  • Hands-on experience with Cytiva AKTA liquid chromatography equipment (AKTA pure, AKTA avant)
  • Hands-on experience with end-to-end biologics purification process development, MSAT, or manufacturing; experience with viral vectors is a plus
  • Experience with statistical design of experiments (DOE) software

Benefits

  • Medical, Dental & Vision
  • Life & Disability Insurance
  • 401(k) Matching
  • Paid Vacation & Holidays
  • Yearly Goal-Based Bonus
  • Merit-Based Increases
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