Principal Process Engineer, Manufacturing Process Development

Terrestrial Bio; Woburn (MA); On-site; USD 140,000 - 170,000; Full time

Job summary

Terrestrial Bio, Inc. is seeking a Principal Process Engineer to lead manufacturing process development for microarray patch production in Woburn, relocating to Allston in November 2026. You will develop predictive models, scale processes, and mentor a growing engineering team.

Experience in GMP environments, DoE, data analysis, and tech transfers is highly valued as you drive through early and late phase programs toward scalable, high-quality manufacturing.

Qualifications

• Experience developing and scaling manufacturing processes for drugs, devices, or combos.
• Strong DoE and data analysis skills.
• Hands-on with equipment and operations to deepen understanding.
• GMP knowledge and experience supporting regulatory filings.

Responsibilities

• Develop predictive models linking process parameters to product quality.
• Scale lab/pilot processes for preclinical/clinical development.
• Lead and mentor engineers to maintain technical excellence as the team grows.
• Collaborate with automation, analytics, and formulation teams to optimize processes.

Skills

Process development

DoE

Data analysis

Leadership

GMP experience

Tech transfer

Regulatory filings

Education

B.S./B.E. in Eng

Tools

DoE software

Data visualization

Job description

Principal Process Engineer, Manufacturing Process Development

Location: Woburn, Moving to Allston in November, 2026

About Terrestrial Bio, Inc.

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.

What Problems You Get to Solve

You will leverage your creativity, analytical mindset, soft skills, and prior process development experience to:

• 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

Making microarray patches with hundreds or thousands of drug-loaded polymer microneedles, and ensuring consistent quality across a patch, a batch, or a manufacturing campaign, requires many processes to go just right, many, many times. This job is about quantifying that sweet spot to inform models and strategies to scale. To that end, you will use your technical expertise to:

• 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 and Background

Core 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.
• Experience leading tech transfers and prior authorship of CMC sections for regulatory filings are preferred.

Preferred Background

• 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.

What Success Looks Like 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!

Come join our team to build enabling technologies for the future of intradermal delivery of therapeutics!

Compensation range

• $140,000 - $170,000