Job Description
Qualifications
B.S. in Chemical, Biomedical, Materials, or Pharmaceutical Engineering, or a related engineering discipline with at least 6 years of relevant process development experience or a M.S. with at least 4 years or Ph.D. with at least 1 year of relevant process development experience
Expertise with process operations such as pumping, mixing, blending, drying, separation, sterile filtration, and aseptic filling
Proven technical judgement and leadership abilities and a demonstrated capacity to conduct and coordinate activities across multiple parallel projects
Strong analytical and critical thinking abilities
Excellent verbal and written communications skills
Willingness to travel domestically and internationally as needed
All candidates must be legally authorized to work in the United States
Benefits
As part of our commitment to enhancing the in-office experience, we provide all employees with a commuter assistance program, offering support of up to $315 per month
Responsibilities
Lead, plan, execute, and document process development experiments, with a focus on generating and analyzing data to develop models characterizing unit operation performance
Apply engineering principles to optimize manufacturing processes to support pre-clinical and clinical production of novel protein microparticle suspensions
Conduct product characterization and process optimization initiatives
Identify opportunities for innovation and continuous improvement in the drug product manufacturing process, and lead initiatives aimed at furthering process knowledge and scale-up strategies
Develop a set of scale up principles from bench to clinical scale taking into consideration the chemical, physical, and stability attributes of protein formulations
Work closely with internal functional groups (analytical, formulation, internal manufacturing) to develop and deliver robust processes and equipment design principles
Use GxP principles to guide process development improvements/scale up strategies with emphasis on late stage/commercialization of drug product entities
Innovation, attention to detail, clear communication/documentation, and ability to collaborate effectively
Document and present results within process development team and cross-functionally
Installation, testing, qualification, and troubleshooting of process equipment and analytical tools
Collaborate and provide mentorship to technical personnel within the Process Development Team
Job 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 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 BiologicsTM.
Position Summary
Elektrofi is seeking a motivated individual to join our biotech company as a Senior Engineer to support process development of the novel Elektrofi formulation platform. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals.
Key Responsibilities
• Lead, plan, execute, and document process development experiments, with a focus on generating and analyzing data to develop models characterizing unit operation performance.
• Apply engineering principles to optimize manufacturing processes to support pre-clinical and clinical production of novel protein microparticle suspensions
• Conduct product characterization and process optimization initiatives.
• Identify opportunities for innovation and continuous improvement in the drug product manufacturing process, and lead initiatives aimed at furthering process knowledge and scale-up strategies.
• Develop a set of scale up principles from bench to clinical scale taking into consideration the chemical, physical, and stability attributes of protein formulations
• Work closely with internal functional groups (analytical, formulation, internal manufacturing) to develop and deliver robust processes and equipment design principles
• Use GxP principles to guide process development improvements/scale up strategies with emphasis on late stage/commercialization of drug product entities
• Innovation, attention to detail, clear communication/documentation, and ability to collaborate effectively
• Document and present results within process development team and cross-functionally
• Installation, testing, qualification, and troubleshooting of process equipment and analytical tools
• Collaborate and provide mentorship to technical personnel within the Process Development Team
MINIMUM QUALIFICATIONS
• B.S. in Chemical, Biomedical, Materials, or Pharmaceutical Engineering, or a related engineering discipline with at least 6 years of relevant process development experience or a M.S. with at least 4 years or Ph.D. with at least 1 year of relevant process development experience
• Expertise with process operations such as pumping, mixing, blending, drying, separation, sterile filtration, and aseptic filling
• Proven technical judgement and leadership abilities and a demonstrated capacity to conduct and coordinate activities across multiple parallel projects
• Strong analytical and critical thinking abilities
• Excellent verbal and written communications skills
• Willingness to travel domestically and internationally as needed
• Experience developing suspension or protein products preferred
• Experience with regulatory expectations for biopharmaceutical development and aseptic manufacturing preferred
• Experience with technical transfer to GMP manufacturing sites preferred
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. As part of our commitment to enhancing the in-office experience, we provide all employees with a commuter assistance program, offering support of up to $315 per month. Please apply at careers@elektrofi.com.
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, ****** 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 United States
