Director of Manufacturing

About Portal Instruments

Portal Instruments is redefining how biologic therapies are delivered. Founded on MIT research, we are building a next-generation drug delivery platform that enables high-volume, high-viscosity biologics to move from IV infusion to subcutaneous injection, unlocking a new generation of at-home therapies.

Our lead platform, PRIME Nexus, combines reusable hardware with software-tunable delivery to enable therapies that were previously not feasible outside the clinic.

We have secured development partnerships with leading biotech companies and are now entering the most critical phase of the company: transitioning from advanced engineering to clinical-ready, scalable manufacturing.

Title:

Director of Manufacturing

Reports to:

CEO

Location:

Boston/Cambridge, MA (on-site presence required)

We are seeking a Director of Manufacturing to build and lead the execution engine that will take our NEXUS platform from advanced engineering to clinical-ready and scalable production. This is a mission-critical leadership role with end-to-end ownership of manufacturing execution, supply chain management, manufacturing readiness and design transfer governance, and production readiness and scale-up.

You will operate at the center of the organization, working across engineering, program management, external partners, and pharma collaborators, to ensure that Portal delivers reliably, predictably, and at scale.

This role is about creating and maintaining the system that builds the product. You will be accountable for ensuring that what is designed can be built, scaled, and delivered on time.

Mission:
Drive the Manufacturing strategy and execution that enables Portal to deliver complex drug delivery systems reliably, at scale, and on time across multiple global pharma partner programs, throughout the lifecycle of the product.

• Manufacturing Strategy & Execution:
  Define and execute the end-to-end manufacturing strategy, lead design transfer from R&D to manufacturing, ensure DFM/DFA principles are embedded early in development, drive readiness for clinical builds, pilot production, commercial launch and scale-up, identify and implement opportunities to drive down cost of goods sold (COGS).
• Process Development & Design Transfer:
  Own the design transfer process, ensuring manufacturing procedures, work instructions, and process validations (IQ/OQ/PQ) are completed to support regulatory submissions (510(k), PMA, or CE mark as applicable). Develop and validate manufacturing processes for precision electromechanical subassemblies, including drive mechanisms, electronic components, sensors, and final device assembly. Partner with R&D to embed Design for Manufacturability (DFM) and Design for Assembly (DFA) principles throughout product development.
  
  Establish and manage process controls, inspection criteria, and process FMEAs to ensure consistent, reproducible output.
• Supply Chain & Vendor Management:
  Lead make‑vs‑buy analyses and manufacturing feasibility assessments; build and manage a supplier base for critical components including actuators, injection‑molded parts, PCBAs, among others. Establish in‑house vs. outsourced manufacturing boundaries; identify, qualify, and manage contract manufacturing organizations (CMOs) and component suppliers. Lead tooling strategy, pilot builds, and production ramp. Ensure alignment across all vendors (scope, timeline, deliverables). Establish supplier qualification programs, incoming quality inspection protocols, and supplier scorecards.
• Quality Systems & Regulatory Compliance:
  Ensure all manufacturing activities comply with 21 CFR Part 820 (QSR), ISO 13485, and applicable IEC standards (e.g., IEC 62133 for battery‑powered devices). Partner with Quality to develop and maintain Device History Records (DHR), Device Master Records (DMR), and supporting documentation. Lead manufacturing readiness for regulatory inspections (FDA, Notified Body) and internal audits. Drive corrective and preventive action (CAPA) processes related to manufacturing nonconformances.
• Program Execution (in partnership with PM):
  Partner with…