Careers

Diagnostics For All (DFA) is an exciting non-profit organization focused on improving global health by creating and commercializing very low cost, easy-to-use, point-of-care medical diagnostic devices for underserved populations in the developing world.  Conveniently located in Cambridge, Massachusetts, we are creating a new generation of diagnostic devices using elegantly simple paper-microfluidics technology, originally developed in the labs of Professor George Whitesides at Harvard University. DFA has received several grants to develop this technology from varied sources including the Bill & Melinda Gates Foundation, USAID, and DARPA.  Please learn more at www.dfa.org.

 

DFA is hiring for the following positions.  For a full description, please follow the links below:

 

Program Manager for a Breakthrough IVD Product (PM-001)

Senior Scientist, Agriculture/Livestock (SS-001)

 

Program Manager for a Breakthrough IVD Product

Position Summary:

Diagnostics For All (“DFA”) is seeking an individual to join our team to manage the Liver Function Test (“LFT”) Program.  The test enables liver function testing close to a patient, and brings this important diagnostic out of the central laboratory.  The LFT is based on DFA’s novel wax-printed paper-based technology and the test will be DFA’s first product to market.  The test has a true dual-market application in the U.S. and developing countries, and it already has the support of a major pharmaceutical company.  

 

We are looking for a full-time program manager who can enable our team to bring this project across the finish line.   This means managing a budget to agreed timelines, and steering the team and the product to a conclusion.

 

 The candidate must have prior experience bringing an In Vitro Diagnostic Device (“IVD”) through the FDA regulatory approval process.  In addition, the candidate would be familiar with taking a product, ideally a diagnostic product, through the manufacturing and commercialization process and have significant experience managing P&L. 

 

There is a steep learning curve, and the candidate is expected to contribute straightway to important regulatory, technical and manufacturing decisions.  The candidate is also expected to be able to manage external contractors and funding partners.

 

This position reports to the CEO.

 

Responsibilities:

 

Project Management

 

    • Create and manage detailed timelines, and cope with change in timelines.

    • Manage and update project budget to align with timeline and deliverables.

    • Manage and communicate deliverables to internal and external stakeholders.

    • Anticipate obstacles, delays and change, and then, together with the DFA team, solve these issues.

    • Manage relationships with sub-contractors.

    • Provide input and updates to project plans, resource tracking, issues, and risks during the project.

    • Prepare reports as necessary, compile agendas, lead a meetings

     

    Technical

     

    • Comfortable managing the science and translating it into a product, but the candidate does not necessarily need to contribute to the science.

    • Sufficient grasp of detail to edit protocols to run the analytical and clinical studies.

    • Experienced with preparation and filing of regulatory submissions, and an ability to steer the technical team through the regulatory process.

    • Lead the selection process of a high volume contract manufacturer.

    • Preparation/Review regulatory submissions (i.e., 510(k)s, PMAs, IDEs, etc.).

    • Management of Clinical Data.

     

    General

     

    • Self–sufficient; an ability to operate effectively without close supervision, but with strong partnership skills and ability to clearly define areas of ownership with various science teams.

    • Collaborate with key stakeholders, balancing competing interests and needs across the organization to arrive at a clear vision, communicating effectively, and aligning various partners along the way.

    • Manage conflict in a project and steer the conflict to an acceptable conclusion.

    • Advanced skills in managing commercial partner relationships.

     

    Qualifications and Experience:

    •  5+ year technical project management or technical leadership in IVD, including P&L responsibility. 
    • Brought at least one IVD product through a 510k or de novo FDA approval process
    • BA or BS, MBA or M.S. preferred.
    • Strong communication skills.
    • Regulatory filings.
    • Clinical Data Management.
    • Analytical, flexible and optimistic.
    • A passion for working on projects directly focused on improving the lives of those living in resource-limited settings.

     

    This is a full-time position.  The successful candidate will have the opportunity to join a small, passionate team developing a novel technology with the potential to positively impact millions of people in the poorest areas around the world.

     

    How to Apply

    Diagnostics For All, Inc. is an equal opportunity employer, which welcomes qualified applicants of all races, ethnicities, genders, and sexual orientations. Candidates should submit a resume and cover letter to Elizabeth Johansen at ejohansen@dfa.org and reference PM-001 in the subject line. No telephone inquiries, please.

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    Senior Scientist, Agriculture/Livestock

    Position Summary:

    DFA is seeking a creative and highly motivated full-time, exempt, Senior Scientist to join our Agriculture/Livestock team. We are currently developing a diagnostic to improve the income of smallholder dairy farmers in East Africa. The science team will analyze the performance of our bovine estrus test in-house and thereafter complete field studies with our African partners. The successful candidate will be expected to work with a research associate to quickly complete verification studies in the lab and then field testing.

     

    We are searching for a candidate with strong technical skills and a passion for solving problems affecting those living in low-resource settings. The successful candidate must have strong past experience in lateral flow assays and immunoassays to hit the ground running. The candidate must have a degree in biomedical engineering, chemical engineering, biology, immunology, biochemistry or materials with 2+ years of experience in diagnostics. Bonus for experience with agriculture/Livestock or international development. The ability to work independently with initiative and creativity is necessary.

     

    Responsibilities:

    • Verification and validation studies on new device
    • Manufacturing optimization of new device
    • Perform field studies with African partners
    • Reports to Program Manager

     

    Qualifications and Experience:

    • M.S. or PhD in biomedical engineering, chemical engineering, biology, immunology, biochemistry, materials, etc.
    • 2+ years of experience in diagnostics, with focus on lateral flow assays and immunoassays
    • Experience organizing large studies and working with multiple vendors/collaborators simultaneously
    • Experience managing and mentoring younger staff
    • Proven written and oral communication skills
    • A passion for working on projects directly focused on improving the lives of those living in resource-limited settings
    • Although not required, prior experience working with large animals in an agricultural setting is a plus

    This is a full-time position.  The successful candidate will have the opportunity to join a small, passionate team developing a novel technology with the potential to positively impact millions of people in the poorest areas around the world.

     

    How to Apply

    Diagnostics For All, Inc. is an equal opportunity employer, which welcomes qualified applicants of all races, ethnicities, genders, and sexual orientations. Candidates should submit a resume and cover letter to Elizabeth Johansen at ejohansen@dfa.org and reference SS-001 in the subject line. No telephone inquiries, please.

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    Diagnostics For All is an equal opportunity employer.