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 highly motivated and detail-oriented Scientist I to join our Process Analytics team within our Analytical Development department. This role will be responsible for developing, qualifying, and performing analytical methods to support process development testing, and perform process analytics, and release testing of our protein therapeutics. This individual will join a multidisciplinary team of scientists and engineers and contribute to a variety of CMC activities in a highly collaborative environment.
Key Responsibilities
Develop and qualify phase-appropriate methods for the characterization and release testing of drug products.
Plan, execute, document and analyze experiments, and present results to a multidisciplinary team.
Interface with collaborators and contract research organizations (CROs) to facilitate method transfer and method qualification activities.
Troubleshoot and resolve testing-related issues.
Maintain accurate records and documentation of test results.
Regularly perform analytical data review and reporting of results.
Author SOPs, technical reports, and certificates of analysis.
Stay current with the latest industry developments and regulatory requirements.
Maintain safe laboratory working conditions following GLP and EHS guidelines.
Serve as a subject matter expert in the investigation of out of specification/trend analytical results
Requirements
MINIMUM QUALIFICATIONS
B.S. Degree required with a preferred focus in Analytical Chemistry, Physical Chemistry, Material Science & Engineering or a similar academic background.
Bachelor’s degree with 5+ years of relevant experience, Master's with 3+ years of relevant experience, or entry-level PhD required.
Excellent critical thinking abilities plus exceptional verbal and written communication skills.
Demonstrated ability to work efficiently in a fast-paced, collaborative R&D environment.
Strong background in method development and characterization of protein therapeutics using various analytical techniques:
Must have working experience with the following techniques: UV-vis spectroscopy, Karl Fischer, Particle Size Analyzer (Laser Diffraction), gas chromatography with flame ionization detection (GC-FID), gas chromatography with mass spectrometry (GC-MS).
Nice to have experience with: Scanning Electron Microscopy (SEM) with Energy Dispersive X-Ray spectroscopy (EDS), Break-Loose Glide-Force analysis, density meter, rheometer, and Brunauer-Emmett-Teller (BET) by inverse gas chromatography (IGC).
Strong attention to detail and ability to document experimental work with electronic laboratory notebooks (ELN).
Experience performing analytical data review and historical data evaluations.
Experience with writing SOPs and technical documents.
General knowledge of cGMP, GLP, and regulatory requirements for pharmaceutical industries.
Familiarity with standard office software (MS Office, Teams, SharePoint).
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 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 United States
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Biotechnology Research
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