Associate Director, Process Engineering

Terrestrial Bio • Woburn, MA

6h • Onsite

About The Position

Terrestrial Bio, Inc. is seeking an innovative, collaborative, experienced Associate Director, Process Engineering to lead technical development of its novel Tacterra™ microarray patch (MAP) manufacturing process. Over the next two years, the company plans to increase process throughput one hundred-fold while improving product quality. The role will lead the team responsible for process development on a new, highly automated pilot-scale MAP line and will require close collaboration with automation engineering, technical operations, and analytical and formulation development.

The Associate Director will lead development of scalable unit operations on small- and intermediate-scale equipment, oversee process-development strategy and execution for lead and pipeline programs, and translate laboratory and pilot-scale data into functional manufacturing processes. The role also contributes to internal documentation and regulatory filings, defines control strategies with formulation and analytical development using a quality-by-design framework, and works with manufacturing engineering and automation teams to evaluate and improve equipment and processes. The successful candidate will lead and develop a team of engineers and technicians.

Within 12 months, the role is expected to develop predictive models linking critical product quality attributes to process parameters and use them to propose normal operating ranges for MAP manufacturing. It is also expected to establish laboratory- and pilot-scale processes supporting preclinical and clinical development of Terrestrial’s lead program. The position is onsite 4–5 days per week, currently in Woburn, Massachusetts, with a planned move to a new facility in Allston in Q4 2026.

Requirements

• B.S., M.S., or Ph.D. in a relevant engineering or scientific discipline.
• At least 8 years of relevant industry experience in process development or manufacturing.
• Prior experience managing engineers or other technical personnel.
• Track record of using engineering and scientific principles to develop and scale manufacturing processes for biopharmaceuticals, medical devices, or combination products.
• Willingness to work onsite 4–5 days per week.

Nice To Haves

• Experience in early- and late-stage development of drug products, medical devices or diagnostics, or combination products.
• Experience with solid dosage forms, polymeric drug delivery, or micro-scale systems.
• Demonstrated experience applying process-development data and models to execute tech transfers, scale-up, scale-out, and establishment of high-throughput manufacturing processes.
• Familiarity with regulatory guidelines for drug products or medical devices.
• Prior experience contributing to or authoring CMC sections of regulatory filings.
• Enjoyment of hands-on work with equipment and operations.

Responsibilities

• Lead a technical team responsible for developing scalable unit operations for producing Tacterra™ microarray patches on small- and intermediate-scale equipment.
• Oversee process-development strategy and execution for lead and pipeline programs.
• Synthesize process data from laboratory- and pilot-scale development into functional manufacturing processes.
• Document process-development progress internally and in regulatory filings.
• Collaborate with formulation and analytical development teams to define control strategies using a quality-by-design framework.
• Work with manufacturing engineering and automation teams to evaluate, operationalize, and improve equipment and processes.
• Lead engineers and technicians and help grow the team to meet future technical needs.
• Develop predictive models that relate critical product quality attributes to relevant process parameters and use them to propose normal operating ranges for MAP manufacturing.
• Establish laboratory- and pilot-scale processes to support preclinical and clinical development of the lead program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior