Lead Engineer I, Pharmaceutical Development, Process Development

Job Description

Job Description

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 Lead Engineer I to support the development of our novel Hypercon™ formulation platform. This individual will drive the technical execution and integration of our platform manufacturing processes across a diverse portfolio of partner development programs. This role is ideal for an experienced engineer who thrives on cross-functional collaboration, technical leadership, and platform standardization. As Lead Engineer I , you will own critical unit operations, guide junior staff, and ensure alignment between platform capabilities and program-specific needs from development through tech transfer. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals.

KEY RESPONSIBILITIES

• Lead the lab execution of development, optimization, and scale-up of platform unit operations (e.g., mixing, TFF, sterile filtration, filling) to support early- and mid-phase clinical programs.
• Serve as the technical lead on one or more development programs, ensuring consistency with platform strategy while accommodating partner-specific requirements.
• Author and review key development documents (protocols, reports, risk assessments, development history reports) to support CMC regulatory submissions.
• Mentor and provide technical oversight to Engineers I–III; promote best practices and continuous improvement within the team.
• Collaborate closely with MSAT, QA, Analytical, Formulation, and Regulatory teams to ensure robust and phase-appropriate process design and documentation.
• Participate in facility fit assessments, equipment strategy, and technology transfer into GMP environments.
• Present technical findings and platform recommendations to internal and external stakeholders.
• 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.

MINIMUM QUALIFICATIONS

• B.S. in Chemical, Biomedical, Materials, or Pharmaceutical Engineering, or a related engineering discipline w/ 5+ years of relevant experience in biopharmaceutical process development, or M.S. w/ 3+ years of relevant experience.
• Strong hands-on experience with bioprocess operations (e.g., TFF, filtration, compounding, mixing, filling).
• Demonstrated ability to lead the lab execution of technical workstreams or cross-functional development projects.
• Familiarity with CMC requirements and expectations for clinical-stage programs.
• Experience with cGxP and aseptic manufacturing is preferred.
• Experience with novel platform development is preferred.
• Experience in processes involving ATEX, Class I Div I, Class I Div II equipment design is a plus.
• Experience working within a platform development framework supporting multiple external programs.
• Experience with single-use systems (SUS), filtration technologies, Downstream DS purification, Drug Product compounding and sterile filtration, and aseptic Fill/Finish.
• Strong communication and organization skills to manage the execution of multiple cross-functional workstreams in parallel.

Our unique strength lies in transforming pioneering ideas into concrete, life-transforming solutions. To realize this ambitious vision, we are dedicated to nurturing an in-office work ethos. While remote work has its merits, it does not constitute a fundamental aspect of our working approach. Please apply at elektrofi.com/careers.

EEOC Statement:

Elektrofi provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

To all agencies, please, no phone calls or emails to any employee of Elektrofi about this requisition. All resumes submitted by search firms/employment agencies to any employee at Elektrofi via email, the internet, or in any form and method will be deemed the sole property of Elektrofi unless such search firms/employment agencies were engaged by Elektrofi for this requisition and a valid agreement with Elektrofi is in place. If a candidate submitted outside of the Elektrofi agency engagement process is hired, no fee or payment of any kind will be paid.

All candidates must be legally authorized to work in the US.

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