Engineer I/II, Process Development

Terrestrial Bio•Woburn, MA
•$60,000 - $90,000•Onsite

About The Position

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1. Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration. Terrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules.

Requirements

  • B.S. in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related discipline with 0-2 years of experience (internship, co-op, or academic research experience) for Process Engineer I
  • 3+ years of relevant hands-on experience in medical devices or pharmaceutical development/manufacturing for Process Engineer II
  • Experience with automated manufacturing equipment or process development strongly preferred
  • Hands-on experience designing, executing, and analyzing process development experiments, with strong data analysis and communication skills
  • Familiarity or experience working in a cleanroom and/or a biomedical laboratory environment
  • Comfort standing or sitting for up to 8 hours, and performing tasks on laboratory benchtops and within glovebox isolators
  • Relevant direct experience in medical devices or pharmaceuticals — internship, co-op, or prior work experience all count
  • Excellent time and project management skills, with a proven ability to meet goals and deadlines
  • Demonstrated ability to learn new skills and fields quickly, think independently, and collaborate across diverse, multidisciplinary teams

Responsibilities

  • Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams
  • Support manufacturing scale-up through hands-on assessment of novel equipment, workflows, analytical techniques/PAT, and process configurations
  • Support phase-appropriate cGMP manufacturing operations by drafting, revising, and reviewing process development histories, master batch records, process and equipment O&M SOPs, and other manufacturing documentation within Terrestrial’s Quality Management System
  • Develop and implement new or improved processes and controls to increase quality and throughput
  • Design tools, fixtures, and machines for manufacturing Terrestrial’s products
  • Collaborate closely with cross-functional teams to support product development and manufacturing activities
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