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Elektrofi · 5 months ago

Senior Engineer II, Pharmaceutical Development, Process Development

Boston- 25 DD

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Elektrofi is revolutionizing the delivery of biologic therapies, enabling convenient at-home subcutaneous self-administration of life-changing medicines. The Sr. Engineer II will lead the technical execution of process development activities for the Hypercon™ formulation platform, ensuring scalability and serving as a link between development, manufacturing, and partners.

Alternative MedicineBiotechnologyTherapeutics

No H1B

Responsibilities

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

Serve as a technical lead on development workstreams 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

Qualification

Process developmentBiomanufacturingTechnical leadershipCGxP complianceAseptic manufacturingData analysisContinuous improvementCommunicationMentoringCross-functional collaboration

Required

B.S. in Chemical, Biomedical, Materials, or Pharmaceutical Engineering, or a related engineering discipline w/ 8+ years of relevant experience in process development or biomanufacturing, or M.S. w/6+ years or Ph.D. w/2+ years of relevant experience

Demonstrated ability to lead process development and cross-functional projects

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

Experience with cGxP and aseptic manufacturing is required

Experience with single-use systems (SUS), filtration technologies, Downstream biologic DS purification, Aseptic Drug Product manufacturing, Fill/Finish or CIP/SIP

Familiarity with platform process design, scalability principles, and QbD methodologies

Strong communication skills and comfort working with internal stakeholders and external partners

Proficiency with data analysis and visualization tools (e.g., JMP, Excel, Minitab)