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Elektrofi · 3 days ago

Lead Engineer I, Pharmaceutical Development, Process Development

Boston, MA

Full-time

Onsite

Mid, Senior Level

$105K/yr - $125K/yr

5+ years exp

Elektrofi is a biotech company revolutionizing the delivery of biologic therapies with their innovative technology platform. The Lead Engineer I will support the development of the Hypercon™ formulation platform, driving technical execution and integration across various partner development programs.

Alternative MedicineBiotechnologyTherapeutics

No H1B

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

Qualification

Biopharmaceutical process developmentBioprocess operationsCMC requirementsAseptic manufacturingSingle-use systemsCommunication skillsOrganization skillsTechnical leadership

Required

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

Strong communication and organization skills to manage the execution of multiple cross-functional workstreams in parallel

Preferred

Experience with cGxP and aseptic manufacturing

Experience with novel platform development

Experience in processes involving ATEX, Class I Div I, Class I Div II equipment design

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