Senior Process Engineer

Terrestrial; Woburn (MA); On-site; USD 107,000 - 130,000; Full time

Job summary

Terrestrial in Woburn, MA is seeking a Senior Process Engineer to help develop manufacturing processes for therapeutic micro-array patches. You will contribute to advancing pipeline programs through clinical development and establish a platform for high-throughput commercial-scale manufacturing.

Responsibilities include designing and analyzing development experiments, supporting scale-up, updating controlled documents, and mentoring junior engineers.

Qualifications

• BS or higher in Engineering (Mechanical, Biomedical, Manufacturing, or related).
• 7-9 years of hands-on R&D experience in medical devices or biopharma; GMP is desirable.
• Experience using empirical and first-principles models to inform experiments; statistical methods a plus.
• Strong time and project management skills and ability to meet deadlines.

Responsibilities

• Characterize and improve manufacturing process unit operations via development experiments; report results.
• Support scale-up by evaluating equipment, workflows, PAT, and configurations.
• Maintain and revise batch records, SOPs, and controlled documents; support Quality System.
• Supervise and mentor junior engineers and technicians, including a direct report.
• Collaborate with cross-functional teams to support product development and manufacturing.

Skills

Process engineering

Data analysis

Statistical methods

Project management

Team leadership

Education

Bachelor's degree in Engineering

Tools

Six Sigma

DoE (Design of Experiments)

Job description

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1. Terrestrial's proprietary Tacterra™ micro-array 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.

The Role

As a Senior Process Engineer at Terrestrial, you will join a team focused on developing innovative manufacturing processes for production of high-quality therapeutic micro-array patches. Your contributions will support advancement of pipeline programs through clinical development, as well as establishment of a platform to enable high-throughput commercial scale manufacturing.

Responsibilities

• Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams
• Support manufacturing scale-up by assessing novel equipment, workflows, analytical techniques/PAT, and process configurations
• Support manufacturing operations by incorporating equipment and process improvements within established processes and equipment trains, and by revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Terrestrial' Quality System
• Supervise and mentor junior engineer(s) and technicians, including a direct report
• Collaborate closely with cross-functional teams to support product development and manufacturing activities

Qualifications

• BS or higher in Engineering (Mechanical, Biomedical, Manufacturing, Materials, or related)
• 7-9 years of relevant, hands-on R&D experience within the medical device or biopharmaceutical industries; experience working on combination products in a GMP environment is highly desirable
• Demonstrated success using empirical and first-principles models to inform and analyze experiments; experience with statistical methodologies and working with large data sets (e.g. Six Sigma, DoEs, multivariate techniques) is a plus
• Excellent time and project management skills and proven ability to meet goals and deadlines
• Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams
• Entrepreneurial spirit and drive to positively impact global human health

The anticipated base salary range for this position is $107,000 - $130,000. Actual compensation will be determined based on a variety of factors including experience, qualifications, and internal equity.

At Terrestrial, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment.