Senior Process Engineer, Biotech Manufacturing Scale-Up

Terrestrial Bio, Inc.; Woburn (MA); Hybrid; USD 140,000 - 170,000; Full time

Job summary

Terrestrial Bio, Inc. in Woburn, MA is seeking a Principal Process Engineer for Manufacturing Process Development to lead the technical development of the microarray patch manufacturing process and to scale throughput while safeguarding product quality.

You will collaborate across automation, analytical, and formulation teams, mentor engineers, build predictive models linking process parameters to quality, and contribute to regulatory filings.

Qualifications

• 8+ years of relevant process engineering experience.
• Experience scaling manufacturing processes for biopharmaceuticals, medical devices, or combination products.
• Hands-on experience with equipment and operations to deepen understanding.
• Experience with GMPs and quality-by-design approaches is preferred.
• Experience leading tech transfers and authorship of CMC sections for regulatory filings is preferred.
• Strong data analysis, DoE, and monitoring of process performance.

Responsibilities

• Characterize and improve manufacturing process unit operations by developing first principles and empirical models.
• Develop tools to analyze and interpret large process data sets; establish relationships between parameters and product quality.
• Mentor and lead junior engineers to maintain technical excellence.
• Assess novel automated manufacturing equipment, workflows, and PAT strategies in collaboration with cross-functional teams.

Skills

Process engineering

Biopharmaceuticals

DoEs

Data analysis

GMPs

Project management

Education

B.S. in Mechanical Engineering

B.S. in Chemical Engineering

Job description

Terrestrial Bio, Inc. in Woburn, MA is seeking a Principal Process Engineer for Manufacturing Process Development to lead the technical development of the microarray patch manufacturing process and to scale throughput while safeguarding product quality.

You will collaborate across automation, analytical, and formulation teams, mentor engineers, build predictive models linking process parameters to quality, and contribute to regulatory filings.