Principal Process Engineer, Manufacturing Process Development

Terrestrial Bio•Woburn, MA

4d•$140,000 - $170,000•Hybrid

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. We are looking for an innovative, collaborative, experienced process engineer to lead technical development of our novel microarray patch manufacturing process. Over the next two years, we will increase process throughput by one hundred-fold while improving product quality. The successful candidate will play a vital role in this effort. The role is multidisciplinary and dynamic, requiring close and proactive collaboration with automation engineering, technical operations, and analytical and formulation development. The ideal candidate will grow alongside our process and operations and bring passion to drive products which make patients’ lives better.

Requirements

Experience using quality-by-design approaches to develop quantitative models in support of process development of drugs, medical devices, or combination products.
Mastery of statistically designed experiments (DoEs) and excellent data analysis / visualization skills.
Relevant and hands-on experience developing and scaling systems and processes for microscale systems, drug delivery, precision fluid dispensing, coating/bonding, drying/curing, or automated inspection and assembly.
Familiarity and experience working with data from analytical methods to assess physical and chemical quality attributes of drugs or device components; experience specifying and integrating PAT preferred.
Prior experience operating under GMPs to support technical operations; late phase or commercial preferred.
Project and people management skills, and prior experience managing other engineers.

Nice To Haves

Experience leading tech transfers and prior authorship of CMC sections for regulatory filings are preferred.
B.S. or higher in Mechanical, Biomedical, Chemical, or Manufacturing Engineering.
8+ years of relevant process engineering experience.
Prior experience managing engineers or other technical personnel.

Responsibilities

Contextualize process tradeoffs within a risk-based product development framework; define and execute a robust development strategy for early and late phase programs; document process development history internally and in regulatory filings.
Partner with Terrestrial’s other functional areas to assess novel automated manufacturing equipment, workflows, analytical techniques/PAT, and process configurations.
Lead a deep and talented team of engineers and technicians and help us grow to meet the technical needs of the future.
Characterize and improve manufacturing process unit operations by developing first principles and empirical models.
Develop and refine tools to analyze and interpret large process data sets; establish quantitative relationships between process parameters and product quality metrics.
Manage, mentor, and inspire junior engineers to maintain technical excellence as the team grows.