Manufacturing Process Engineer
4 days ago
About Elektrofi, Inc.
We are revolutionizing the delivery of biologic therapies by empowering patients to control their treatment experience. Our ultra-high concentration microparticle technology platform addresses limitations associated with intravenously administered biologic therapies, enabling convenient at-home subcutaneous self-administration.
With a focus on monoclonal antibodies, therapeutic proteins, and other large molecule drugs, we develop, commercialize, and deliver subcutaneous biologic therapies in collaboration with strategic partners.
Role Summary
We seek an experienced Senior Manufacturing Process Engineer to join our multidisciplinary team and contribute to the process development of our novel formulation platform.
The successful candidate will lead experiments, generate and analyze data, and optimize manufacturing processes to support pre-clinical and clinical production of novel protein microparticle suspensions.
Key Responsibilities
- Develop, execute, and document process development experiments to advance unit operation performance modeling.
- Apply engineering principles to enhance manufacturing efficiency, scalability, and product quality.
- Conduct thorough product characterization and process optimization initiatives.
- Identify opportunities for innovation and improvement in drug product manufacturing processes and drive scale-up strategies.
- Collaborate with internal functional groups to design and implement robust processes and equipment principles.
- Ensure compliance with GxP regulations and industry best practices throughout process development and scale-up.
- Effectively communicate results within the process development team and cross-functionally.
- Maintain, test, qualify, and troubleshoot process equipment and analytical tools.
- Promote knowledge sharing and provide mentorship to technical personnel within the Process Development Team.
Requirements
- Bachelor's or Master's degree in Chemical, Biomedical, Materials, Pharmaceutical Engineering, or a related field; minimum 6 years of relevant process development experience or Ph.D. with at least 1 year of experience.
- Extensive knowledge of process operations, including pumping, mixing, blending, drying, separation, sterile filtration, and aseptic filling.
- Demonstrated leadership abilities, technical expertise, and project coordination skills.
- Strong analytical and critical thinking abilities, with excellent written and verbal communication skills.
- Willingness to travel domestically and internationally as needed.
- Preferred experience in suspension or protein product development and regulatory expectations for biopharmaceutical development and aseptic manufacturing.
Benefits
Elektrofi offers a competitive salary range of $130,000 - $160,000 per annum, depending on qualifications and experience, plus commuter assistance program and comprehensive benefits package.
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