ASSOCIATE/ SENIOR ASSOCIATE

ABOUT 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. www.Elektrofi.com.

POSITION SUMMARY

Elektrofi is seeking a highly motivated and detail-oriented Associate/Senior Associate to join our Analytical Department who will be responsible for developing, qualifying, and performing analytical methods to support process development testing, perform process analytics and batch testing of our drug products. This individual will join a multidisciplinary team of scientists and engineers and contribute to a variety of CMC activities in a fast-paced, agile and highly collaborative environment.

KEY RESPONSIBILITIES

• Routinely perform batch and stability testing of drug products using qualified methods.
• Troubleshoot and resolve testing-related issues.
• Maintain accurate records and documentation of test results.
• Regularly perform analytical data review and reporting of results.
• Participate in internal and external audits.
• Stay current with the latest industry developments and regulatory requirements.
• Aid in development and qualification of process analytical assays.
• Support technology transfer of process analytical methods to external parties.
• Maintain safe laboratory working conditions following GLP and EHS guidelines.

QUALIFICATIONS

• Required: Bachelor's degree with 2 to 4 years or Master's degree with 1 to 2 years of industry experience, in Chemistry or a related field.
• Required: Hands-on experience required in any of the following: gas chromatography with flame ionization detection (GC-FID), Karl Fischer, Particle Size Analyzer (Laser Diffraction), UV-vis spectroscopy, Scanning Electron Microscopy (SEM), Break-Loose Glide-Force analysis, and density measurements.
• Required: General knowledge of cGMP, GLP, and regulatory requirements for biotech and pharmaceutical industries is highly desirable.
• Required: Strong attention to detail and ability to document experimental work with electronic laboratory notebooks (ELN) is a must.
• Experience performing analytical data review and historical data evaluations.
• Experience with writing SOPs and technical documents.
• Familiarity with standard office software (MS Office, Teams, SharePoint).
• Ability to work in a fast-paced, agile and highly collaborative environment is essential

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 $300 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, 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.