Senior Process Engineer

Location: Woburn, moving to Allston

Terrestrial (formerly known as Vaxess) is developing a pipeline of next-generation vaccines and therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the self-applied patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Terrestrial is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role:

As a Senior Process Engineer at Vaxess, 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 Vaxess’ 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