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 motivated individual to join our biotech company as a Manager, Document Management & Training to support the development of the novel Elektrofi formulation platform. The individual will join as a temp-to-perm role with a growing, multidisciplinary team of scientists/engineers and industry professionals.

A successful candidate will be responsible for the overall establishment and management of Elektrofi Document Management System and the GxP Training Program. This person will work cross-functionally with other functions to ensure the Document Management System is designed and implemented meeting the biotech/pharmaceutical industry standards and requirements.

KEY RESPONSIBILITIES

• Responsible for the overall implementation and management of Elektrofi document control system and processes, and the GxP Training Program.
• Establish a document management system for R&D and GxP documentation to ensure documents, data, and records are controlled and data integrity is maintained.
• Serve as the system owner and functional lead for Document Management System
• Partner cross-functionally to develop, maintain and administer SOPs, guidelines, and training to meet company, industry, and regulatory standards.
• Manage and oversee the overall document lifecycle that would include document initiation, review, approval, distribution, obsoletion, storage/archive, tracking and trending.
• Provide support as needed in hosting Partners’ audits and Partners’ and Elektrofi’s regulatory submissions.
• Coordinate workflows with task owners to ensure that documents are properly reviewed, issued, closed, and/or obsoleted within specified timeframes.
• Develop and deliver GxP training programs and manage/maintain Elektrofi training program.
• In collaboration with IT support, lead inquiry, assessment, evaluation, and recommendation for onboarding an electronic Document Management System (eDMS).
• Assist in the execution of other Quality Management System (QMS) responsibilities as needed.
• Perform other related duties as required.

QUALIFICATIONS

• Bachelor’s degree or equivalent work experience required, preferably in a scientific or technical discipline.
• 5 years of experience working in designing, implementing, and/or maintaining a Document Management System in a biotech/pharmaceutical industry within R&D and/or GxP environment.
• Experience planning and implementing electronic Document Management System (eDMS).
• Ability to write SOPs specific to Document Control processes.
• Ability to work cross-functionally across all levels of the company.
• Highly organized and detailed-oriented.
• Proficiency with SharePoint and Microsoft tools.
• Strong problem solving, critical thinking, and analytical skills to make evidence-based decisions.
• Skilled at building and cultivating stakeholder confidence.
• Self-starter working in a fast-paced environment with a can-do mindset to advance the company’s goals.
• Ability to manage multiple projects at times, establish priorities, and meet deadlines to support our client/partner needs.

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.