Senior Process Engineer

Terrestrial BioWoburn, MA
$107,000 - $130,000

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. For more information, visit www.terrestrialbio.com. As a Senior Process Engineer at Terrestrial, you will join a team focused on developing innovative manufacturing processes for production of high-quality therapeutic micro-array patches. Your contributions will support advancement of pipeline programs through clinical development, as well as establishment of a platform to enable high-throughput commercial scale manufacturing.

Requirements

  • BS or higher in Engineering (Mechanical, Biomedical, Manufacturing, Materials, or related)
  • 7 – 9 years of relevant, hands-on R&D experience within the medical device or biopharmaceutical industries; experience working on combination products in a GMP environment is highly desirable
  • Demonstrated success using empirical and first-principles models to inform and analyze experiments; experience with statistical methodologies and working with large data sets (e.g. Six Sigma, DoEs, multivariate techniques) is a plus
  • Excellent time and project management skills and proven ability to meet goals and deadlines
  • Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams
  • Entrepreneurial spirit and drive to positively impact global human health

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 by assessing novel equipment, workflows, analytical techniques/PAT, and process configurations
  • Support manufacturing operations by incorporating equipment and process improvements within established processes and equipment trains, and by revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Terrestrial' Quality System
  • Supervise and mentor junior engineer(s) and technicians, including a direct report
  • Collaborate closely with cross-functional teams to support product development and manufacturing activities
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