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Elektrofi · 3 weeks ago

Principal Engineer/Senior Engineer II, Process Development

Boston, MA

Full-time

Onsite

Senior Level, Lead/Staff

$135K/yr - $155K/yr

8+ years exp

Elektrofi is a biotech company revolutionizing the delivery of biologic therapies through innovative technology. The Principal Engineer/Senior Engineer II will lead the technical execution of platform process development activities, ensuring scalability and serving as a critical link between development, manufacturing, and external partners.

Alternative MedicineBiotechnologyTherapeutics

No H1B

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 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 developmentGMP environmentsTechnical leadershipBiologic drug productsData analysis toolsContinuous improvementMentorshipCommunication skillsCollaboration

Required

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

Preferred

Experience with novel platform development is preferred

Experience developing biologic drug products or parenteral suspensions is preferred

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

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)