Jobs at Terrestrial

We are looking for an innovative, collaborative, experienced Associate Director, Process Engineering, to lead technical development of our novel MAP 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 by leading the team responsible for process development on a brand-new, highly automated pilot scale MAP line. 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.

• Lead a technical team responsible for development of scalable unit operations for production of Tacterra™ MAPs on small and intermediate scale equipment
• Oversee strategy and execution of process development for lead and pipeline programs; synthesize process data from lab-scale and pilot-sale development into highly functional manufacturing processes; document process development progress internally and in regulatory filings.
• Collaborate closely with formulation and analytical development teams to define control strategies using a quality-by-design framework; work with manufacturing engineering and automation functions to evaluate, operationalize, and improve equipment and processes
• Lead a deep and talented team of engineers and technicians and help us grow to meet the technical needs of the future.

Required:

• B.S., MS or Ph.D. in a relevant engineering or scientific discipline
• 8+ years relevant industry experience in process development or manufacturing
• Prior experience managing engineers or other technical personnel

Preferred candidates will have:

• Experience working in early and late-stage development of drug products, medical devices / diagnostics, or combination products; solid dosage forms, polymeric drug delivery, or micro-scale systems preferred
• Demonstrated experience applying process development data and models to efficiently execute tech transfers, scale-up, scale-out, and establishment of high throughput manufacturing processes
• Familiarity with regulatory guidelines for drug products or medical devices, and prior experience contributing to or authoring CMC sections of regulatory filings