Elektrofi, Inc.
Senior Scientist, Analytical Development
Elektrofi, Inc., Boston, Massachusetts, us, 02298
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 talented and motivated individual to join our biotech company full-time as a Senior Scientist joining our Analytical Development’s Particulates team 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 join a team responsible for the development and qualification of analytical methods for characterizing various categories of particulates (inherent/proteinaceous, intrinsic, and extrinsic). They will work with a multidisciplinary team of scientists and engineers and contribute to a variety of CMC activities in a highly collaborative environment.
KEY RESPONSIBILITIES
Develop and implement robust analytical methods for material identification of foreign (intrinsic and extrinsic) particulates in drug products by leveraging prior relevant experience, regulatory guidance, and Quality-by-Design principles.
Perform sample analysis and interpret data to identify and quantify particulates.
Write and review SOPs, method and instrument qualification protocols, technical reports, certificates of testing, CMC sections of regulatory filings, and ELN entries.
Collaborate with other team members to ensure that analytical methods are aligned with product development goals.
Serve as a subject matter expert to support technical transfer (method transfer) to external laboratories and contribute to investigations of out-of-specification or out-of-trend analytical results.
Stay current with industry trends and new analytical techniques to continuously innovate on our methods and processes.
MINIMUM QUALIFICATIONS
Ph.D. in Materials Science, Analytical Chemistry, Pharmaceutical Science, or a related field, plus at least three years of relevant experience required.
Relevant experience in investigational characterization of foreign particulates using Raman spectroscopy, scanning electron microscopy energy dispersive x-ray spectroscopy (SEM-EDS), laser-induced breakdown spectroscopy (LIBS), and Fourier-Transform Infrared (FTIR) Spectroscopy is highly desirable.
Familiarity with relevant regulatory and compendial guidance is desirable.
Experience in method development and characterization of visible particulates (VPs), subvisible (SVPs), and submicron (SMPs) particulates by various analytical techniques.
Familiarity with biochemical methods typically used for protein analysis is a plus.
Good understanding of GMP regulations in a development setting and experience working within CRO labs desirable.
Excellent critical thinking abilities plus exceptional verbal and written communication skills.
Demonstrated ability to work efficiently in a fast-paced, collaborative R&D environment.
Good attention to detail and the ability to thoroughly document work with electronic laboratory notebooks.
Familiarity with standard Microsoft Office suite (MS Office, Teams, SharePoint, etc.).
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, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
All candidates must be legally authorized to work in the United States
#LI-Onsite
#J-18808-Ljbffr
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 talented and motivated individual to join our biotech company full-time as a Senior Scientist joining our Analytical Development’s Particulates team 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 join a team responsible for the development and qualification of analytical methods for characterizing various categories of particulates (inherent/proteinaceous, intrinsic, and extrinsic). They will work with a multidisciplinary team of scientists and engineers and contribute to a variety of CMC activities in a highly collaborative environment.
KEY RESPONSIBILITIES
Develop and implement robust analytical methods for material identification of foreign (intrinsic and extrinsic) particulates in drug products by leveraging prior relevant experience, regulatory guidance, and Quality-by-Design principles.
Perform sample analysis and interpret data to identify and quantify particulates.
Write and review SOPs, method and instrument qualification protocols, technical reports, certificates of testing, CMC sections of regulatory filings, and ELN entries.
Collaborate with other team members to ensure that analytical methods are aligned with product development goals.
Serve as a subject matter expert to support technical transfer (method transfer) to external laboratories and contribute to investigations of out-of-specification or out-of-trend analytical results.
Stay current with industry trends and new analytical techniques to continuously innovate on our methods and processes.
MINIMUM QUALIFICATIONS
Ph.D. in Materials Science, Analytical Chemistry, Pharmaceutical Science, or a related field, plus at least three years of relevant experience required.
Relevant experience in investigational characterization of foreign particulates using Raman spectroscopy, scanning electron microscopy energy dispersive x-ray spectroscopy (SEM-EDS), laser-induced breakdown spectroscopy (LIBS), and Fourier-Transform Infrared (FTIR) Spectroscopy is highly desirable.
Familiarity with relevant regulatory and compendial guidance is desirable.
Experience in method development and characterization of visible particulates (VPs), subvisible (SVPs), and submicron (SMPs) particulates by various analytical techniques.
Familiarity with biochemical methods typically used for protein analysis is a plus.
Good understanding of GMP regulations in a development setting and experience working within CRO labs desirable.
Excellent critical thinking abilities plus exceptional verbal and written communication skills.
Demonstrated ability to work efficiently in a fast-paced, collaborative R&D environment.
Good attention to detail and the ability to thoroughly document work with electronic laboratory notebooks.
Familiarity with standard Microsoft Office suite (MS Office, Teams, SharePoint, etc.).
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, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
All candidates must be legally authorized to work in the United States
#LI-Onsite
#J-18808-Ljbffr