Principal Process Engineer, Manufacturing Process Development

Terrestrial; Woburn (MA); Presencial; USD 145.000 - 170.000; Jornada completa

Descripción de la vacante

Terrestrial is seeking an innovative, collaborative Process Engineer to lead the technical development of our microarray patch manufacturing process in Woburn, MA, with Allston, MA relocation planned for Q4 2026. The role requires hands-on process engineering, GMP experience, and strong collaboration across operations, automation, analytics, and formulation teams.

You will develop predictive models linking product quality attributes to process parameters, establish lab/pilot scale processes, and

Formación

• Experience applying engineering/physical science to scale manufacturing.
• Experience using quality-by-design approaches to support process development.
• Familiarity with regulatory filings (CMC) is a plus.
• Strong data analysis and visualization skills.

Responsabilidades

• Characterize and improve manufacturing process unit operations using first principles and empirical models.
• Develop tools to analyze large process data sets and relate parameters to product quality metrics.
• Lead, mentor, and inspire junior engineers as the team grows.
• Collaborate with automation, analytical and formulation development teams to optimize workflows.
• Support tech transfers and regulatory filing activities as needed.

Conocimientos

Process engineering

DOE design

Data analysis

Scale-up

Educación

BS in Mechanical/Biomedical/Chemical/Manufacturing Eng

Herramientas

PAT

DoE

GMP

Descripción del empleo

Location: Woburn, Moving to Allston in Q4, 2026, Onsite. 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.

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.

Why this role

• 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.

You will face ambiguity, competing priorities, evolving strategies, and novel systems, and join a company moving quickly toward larger‑scale operations. You will view every challenge as a growth opportunity.

Why This Role Is Compelling

About

• 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.

What Makes Someone a Strong Fit

• You have a track record of successfully using engineering and scientific principles to develop and scale manufacturing processes for biopharmaceuticals, medical devices, or combination products.
• You enjoy getting your hands on equipment and operations to deepen your understanding.
• You think creatively, enjoy solving problems, and contextualize your approach within broader strategies.
• You lead by example and bring out the best in your team.
• 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.
• Experience leading tech transfers and prior authorship of CMC sections for regulatory filings are preferred.

Who You Are

• 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.

Your Impact

Within 12 Months You Will Have

• Developed predictive models relating the critical product quality attributes to the relevant process parameters, and used them to propose normal operating ranges for microarray patch manufacturing.
• Established lab and pilot scale processes to support preclinical and clinical development for Terrestrial’s lead program. Come join our team to build enabling technologies for the future of intradermal delivery of therapeutics!

Compensation:

The anticipated base salary range for this position is $140,000 - $170,000. Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.

Onsite expectations:

The majority of our roles at Terrestrial are either onsite or hybrid, which allows us to meet both business and team needs. Candidates applying must be willing to be onsite 4-5 days per week.

Location:

Woburn, MA and our new, custom facility in Allston MA planned for Q4 of 2026.

At Terrestrial, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. We aim to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.