Principal Engineer​/Senior Engineer II, Process Development

Description

ABOUT ELEKTROFI

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 large molecule drugs, we create, develop, and commercialize subcutaneous biologic therapies in collaboration with strategic partners.

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 .

POSITION SUMMARY

Elektrofi is seeking a motivated individual to join our biotech company as a Principal Engineer/Sr. Engineer II to support the development of our novel Hypercon formulation platform. This individual will lead and support the technical execution of platform process development activities across a diverse portfolio of partner programs. As Principal Engineer/Sr. Engineer II you will contribute deep technical expertise across one or more unit operations, ensure scalability of platform processes, and serve as a critical link between development, manufacturing, and external partners.

This role is ideal for an experienced engineer ready to lead cross-functional efforts, mentor junior staff, and drive platform adaptability to meet evolving program needs. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals.

Key Responsibilities

* Lead the development and lifecycle management of platform unit operations (e.g., Downstream DS Purification, Bulk DP Formulation, Fill/Finish) supporting early- and late-phase clinical programs.

* Define and refine process design spaces, control strategies, and critical process parameters (CPPs) aligned with platform standards and partner needs.

Design and execute platform and program process development studies including mixing, TFF, sterile filtration, and filling.

* Serve as a technical lead on development work streams supporting platform improvement and tech transfer to GMP manufacturing site.

* Analyze data, identify trends, and define critical process parameters and critical quality attributes.

* Author and review technical documentation including protocols and reports to support CMC regulatory submissions.

* Interface with Manufacturing Sciences & Technology (MSAT), QA, Analytical, and partner-facing teams to align technical deliverables.

* Mentor junior engineers and contribute to the growth of technical and operational best practices.

* Support continuous improvement of the platform to enhance scalability, robustness, and program flexibility.

* Identify and follow through on opportunities for innovation and continuous improvement in the drug product manufacturing process, and lead initiatives aimed at improving process knowledge and scale-up strategies.

* Provide direct management oversight of 1-2 technical personnel.

* Ability to travel up to 10% to support international Tech Transfer to CMO.

Requirements

MINIMUM QUALIFICATIONS

* B.S. in Chemical, Biomedical, Materials, or Pharmaceutical Engineering, or a related engineering discipline w/ 10+ years or M.S. w/ 8+ years or Ph.D with 4+ years of experience in process development, pharmaceutical manufacturing, or related discipline.

* Demonstrated ability to lead process development and cross-functional projects.

* Experience leading tech transfer to GMP environments and authoring regulatory documentation.

* Proven technical and strategic leadership in cross-functional teams and ability to communicate with stakeholders and partners.

* Ability to influence technical strategy and collaborate with external partners and senior leadership.

* Demonstrated history of personnel management and mentorship.

* Experience with cGxP and aseptic manufacturing is required.

* Experience with novel platform development is preferred.

* Experience developing biologic drug products or…