Associate Director, Manufacturing Science and Technology

Description

Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously administered biologic therapies by enabling convenient at-home subcutaneous self-administration. With a focus on monoclonal antibodies, therapeutic proteins, and other biologics, we partner with companies to develop and commercialize our novel Hypercon™ formulations.

We believe a patient-centered healthcare approach can lead to a healthier world. We are headquartered in Boston and innovate globally. We are Formulating the Future of Biologics™.

Elektrofi is seeking a highly motivated and experienced Associate Director, Manufacturing Science and Technology (MSAT) to lead the engineering, equipment, and facility readiness initiatives for our proprietary Hypercon™ formulation technology. This role will report to the Sr. Director, Head of Manufacturing Science & Technology and will focus on equipment design, facility start-up, commissioning, qualification, and validation (CQV) activities in support of new manufacturing capabilities at internal and external sites.

The Associate Director will play a critical role in shaping Elektrofi’s technical operations network by managing the design and deployment of robust, scalable, and compliant systems that enable successful clinical and commercial manufacturing. This individual will partner closely with Process Development, Engineering, Quality, Program Management, and CDMO partners to ensure new facilities and equipment are designed and qualified to meet current and future business needs.

• Perform all duties in accordance with Elektrofi’s core values, policies, and cGMP regulations.
• Lead equipment design, procurement, installation, commissioning, and qualification for new Hypercon™ formulation suites and associated support systems.
• Serve as technical lead and owner for MSAT engineering projects including new facility design, utilities, automation, and process equipment integration.
• Partner with Engineering and Quality functions to develop and execute commissioning and qualification (CQV) master plans, FAT/SAT protocols, and IOQ documentation.
• Manage external engineering firms, equipment vendors, and system integrators to deliver projects on time, within budget, and in compliance with regulatory expectations.
• Provide technical expertise in process equipment specification, layout optimization, material flow, and contamination control strategies for aseptic formulation and filling operations.
• Collaborate with Process Development and Engineering teams to ensure seamless tech transfer from lab to manufacturing scale, ensuring process and equipment compatibility.
• Author, review, and approve technical documents including URSs, validation protocols, deviation reports, and risk assessments.
• Support readiness for facility start-up and regulatory inspections by ensuring technical documentation and equipment qualification packages are complete and compliant.
• Apply Lean Six Sigma and risk-based methodologies to optimize equipment performance, reduce downtime, and improve system reliability.
• Act as a key MSAT representative in cross-functional project teams, supporting Elektrofi’s strategic growth and manufacturing network expansion.

Requirements

• B.S. or M.S. in Engineering (Mechanical, Chemical, or related field required; advanced degree preferred).
• 10+ years of experience in the biopharmaceutical or biologics industry, with at least 5 years in MSAT, Engineering, or Technical Operations supporting GMP manufacturing.
• Proven track record in equipment and facility design, start-up, commissioning, and validation for biopharmaceutical manufacturing environments.
• Demonstrated experience managing CDMOs, engineering firms, and equipment suppliers through design and CQV project phases.
• In-depth understanding of GMPs, FDA/EMA expectations, ISPE baseline guides, and ASTM E2500 principles.
• Experience supporting…