Senior Engineer II, 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 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 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

• 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.

MINIMUM QUALIFICATIONS

• 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 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).

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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