- Provide technical leadership of process development projects, including feasibility assessments and basic performance evaluation for novel unit operations, and thorough characterization and optimization of established unit operations.
- Identify and follow through on opportunities for innovation or improvement in the drug product manufacturing process, and lead initiatives aimed at establishing process knowledge and scale-up strategies.
- Develop GMP manufacturing process and collaborate with the External Manufacturing group on technical transfer to contract development and manufacturing organizations.
- Represent process development on cross functional teams and initiatives.
- Lead program-specific process development activities and collaborate with external biotech and pharma partners
- Provide direct management oversight of a small team of technical personnel.
- chemical engineering, mechanical engineering, chemistry, materials science, or other relevant discipline with 7-10 years or M.S. with 5+ of relevant experience in process development required, preferably in the biopharmaceutical industry.
- Expertise with process operations such as pumping, mixing, blending, liquid handling, drying, separation/filtration, and fill-finish preferred.
- Proven technical judgement and leadership abilities and a demonstrated capacity to work independently on multiple parallel projects.
- Excellent verbal and written communications skills.
- Prior experience managing technical personnel.
- Some exposure to GMP manufacturing preferred.
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Senior Engineer - Boston, United States - Elektrofi
Description
SENIOR ENGINEER I/IIABOUT ELEKTROFI
Elektrofi is a biopharmaceutical formulation technology company that 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 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. Formulating the Future of Biologics.
POSITION SUMMARY
Elektrofi is seeking a talented and motivated individual to join our biotech company full-time as a Senior Engineer I/II in Process Development to support the development of the novel Elektrofi formulation platform. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals. A successful candidate will accelerate the development and scale-up of our manufacturing processes. This individual will assume a key technical role within an established team of engineers by leading and overseeing engineering projects across multiple critical workstreams, with an emphasis on scale-up and commercialization.
KEY RESPONSIBILITIES
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.
The candidate must be authorized to work in the US.
