Join us in developing transformational products for patients in the fight against cancer and immune mediated diseases.

NexImmune is an early stage biotech company developing unique products that harness the power of the natural immune system to treat cancer and other life-threatening diseases. We are seeking highly skilled and motivated individuals to join an entrepreneurial team of experienced professionals dedicated to science, patients and addressing diseases with significant unmet need.  We are uncompromising in our commitment to shared values, a strong work ethic, respect for individuals, and a healthy work/life balance.  The Company focuses on setting clear expectations, empowering people to succeed, and rewarding results.

Benefits include competitive salaries, a 401k retirement plan, health and dental plans, paid vacation (in addition to paid holidays), and opportunities to participate in equity ownership.

NexImmune is an equal opportunity employer and employment decisions are made without regard to sex, race, age, disability, religion, national origin, color or any other protected class.

NexImmune fun in the lab
NexImmune Team
NexImmune serious in the lab
NexImmune working in the lab
  • Research Associate/Senior Research Associate in Molecular Biology

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com

    Department: Molecular Engineering

    Reports To: Senior Vice President, Molecular Engineering & Protein Design

    Status: Full Time/Exempt

    Position Summary:

    The Research Associate in Molecular Biology will act as a scientific contributor for the Molecular Engineering & Protein Design (MEPD) Department’s support of the development of novel nanoparticle, artificial antigen presenting cell (aAPC) based upon NexImmune’s proprietary aAPC technologies. The candidate will assist in the culture and/or modification of mammalian cells, the molecular design, expression and testing of new plasmid DNA vectors for the production of aAPC ligand molecules. Laboratory skills, notebook recording/maintenance, and writing of reports in acceptable scientific format(s) are important.

    Essential Duties and Responsibilities:

    • Assist in the culture of mammalian cell lines.
    • Preparation and transfection of plasmid DNA into mammalian cells and selection of stable lines.
    • Isolation of both mRNA and small RNA from mammalian cell lines.
    • Set up, running and analysis of RT-PCR reactions.
    • Perform ELISA and reporter gene assays.
    • Order supplies and reagents, maintain inventory records.
    • Write reports and protocols.

    Education and Experience:

    • B.S. (M.S. preferred) in Molecular Biology, Biochemistry or related field.
    • Experience working in mammalian cell culture.
    • Experience with isolating both mRNA and proteins from mammalian cells.
    • Experience in the construction and preparation of plasmid DNA vectors.
    • Experience performing and analyzing RT-PCR experiments.
    • Experience with bioinformatics tools, SnapGene, Sequencher, and NCBI database.
    • Demonstrated proficiency in Microsoft Office, including Word, Excel, and PowerPoint.

    Desired Key Competencies:

    • Excellent communication skills.
    • Self motivated and independently minded.
    • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
    • Self-organizer, meticulous hands-on habits, keen attention to detail.
    • Strong quantitative and analytical skills.
    • Responsive, can-do attitude.
    • Can coordinate parallel task across multiple projects, demonstration prioritization.
    • Ability to quickly adapt to a rapidly changing environment and demands.
    • Ability to interpret and effectively execute upon a variety of instruction provided in written, oral, diagram or schedule formats.

    Work Environment:

    Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; color vision; peripheral vision; ability to adjust focus.

    Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/or move up to 10 lbs.

    General: Moderate noise level, similar to typical office environment with computers, printers and light traffic.

    Qualified, interested candidates should send a resume to: admin@neximmune.com

  • Research Associate/Scientist Cell Biology/Immunotherapy

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com

    Department: Preclin. Immunotherapy (PCI

    Reports To: VP

    Status: Full Time/Exempt

    Position Summary:

    The Research Associate/Scientist in Cell Biology/Immunotherapy will act as a scientific contributor for the Preclinical Immunotherapy Department developing and optimizing a new clinical approach to adoptive T cell therapy, based upon NexImmune’s proprietary artificial Antigen Presenting Cell (aAPC) technologies. The candidate will assist in the generation and phenotypical and functional characterization of antigen-specific T cells. Laboratory skills, notebook recording/maintenance, and writing of reports in acceptable scientific format(s) are important.

    Essential Duties and Responsibilities:

    • Assist in the culture of mammalian cell lines.
    • Isolation and expansion of Antigen-specific T Cells.
    • FACS analysis
    • Perform ELISA an protein assays.
    • Order supplies and reagents, maintain inventory records.
    • Write reports, protocols and SOP's

    Education and Experience:

    • M.S. or Ph.D. in Life science (Immunology, Biology, Biochemistry, Biochemistry or related field.
    • Experience in Immunology and T cell biology
    • Experience working in mammalian cell culture, sterile techniques.
    • Experience with FACS
    • Experience ELISA and other plate reader assays
    • Experience performing and analyzing RT-PCR experiments.
    • Experience with HPLC, FPLC
    • Experience with animal (mouse) models
    • Demonstrated proficiency in Microsoft Office, including Word, Excel, and PowerPoint.

    Desired Key Competencies:

    • Excellent communication skills.
    • Self-motivated and independently minded.
    • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
    • Self-organizer, meticulous hands-on habits, keen attention to detail.
    • Strong quantitative and analytical skills.
    • Responsive, can-do attitude.
    • Can coordinate parallel tasks across multiple projects, demonstrating prioritization.
    • Ability to quickly adapt to a rapidly changing environment and demands.
    • Ability to interpret and effectively execute upon a variety of instructions provided in written, oral, diagram or schedule formats.

    Work Environment:

    Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; color vision; peripheral vision; ability to adjust focus.

    Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/or move up to 10 lbs.

    General: Moderate noise level, similar to typical office environment with computers, printers and light traffic.

    Qualified, interested candidates should send a resume to: admin@neximmune.com

  • Sr. Manager/Assoc. Dir/Dir Manufacturing Technical Operations

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com

    Department: Manufacturing

    Reports To: Chief Business Officer

    Status: Full Time/Exempt

    Position Summary:

    This position is responsible for developing and maintaining GMP compliant processes and delivering material for clinical and ultimately commercial development. This includes ensuring, through key partners, quality systems, document control and archive, change control, training requirements, reports, and CAPA systems are in place in a stage appropriate manner meeting all regulatory and quality requirements. This position supports the drug product manufacturing process with the following responsibilities.

    Essential Duties and Responsibilities:

    • Ensuring all aspects of the clinical manufacturing process meet cGMP requirements, including clinical grade reagents, materials, processes and facilities.
    • Developing a central tracking system for programs, reporting and quality controls across CMO facilities.
    • Assemble all necessary material to support CMC in the IND submission and develop CMC Sections of the IND package in collaboration with internal and partner experts for review. Additionally, as programs progress, define future process modification needs, timing and documentation for future regulatory submissions (clinical and commercial product)
      • Develop and track detailed manufacturing plan, identify key scenarios.
      • Facilitate all aspects of cGMP protein manufacturing, including stable cell line development MCB development and that all testing (sterility, viral clearance, stability) for source and final proteins are place.
      • Finalize testing and release plans for the aAPC ensuring all assays developed and testing kits used are in place in alignment with FDA feedback. Determine stability needs for adequate storage of both the P1 material and the aAPC for future use.
      • Develop plan and timelines for assay qualification across all components
      • Identify risk and propose mitigation plans for CMC operations
    • Identify and assess additional manufacturing partners for late stage development, commercial scale up and future expansion of the platform across all aspects.
    • Manage partnerships and coordination across CMO’s and track budgets against current and future timelines and plans.

    Education and Experience:

    • B.S. in Life Science or Chemical engineering required
    • 3+ years technical Manufacturing, Process engineering
    • 1+ years in a cGMP manufacturing setting of biologics
    • Full understanding of current Good Manufacturing Practices is required
    • This role requires a working knowledge of Microsoft Office based programs for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports.
    • Familiarity with analytical instrumentation and cGMP process equipment is required
    • Superior customer facing skills that instill client confidence.

    Desired Key Competencies:

    • Excellent communication skills.
    • Self motivated and independently minded.
    • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
    • Self-organizer, meticulous hands-on habits, keen attention to detail.
    • Strong quantitative and analytical skills.
    • Responsive, can-do attitude.
    • Can coordinate parallel tasks across multiple projects, demonstrating prioritization.
    • Ability to quickly adapt to a rapidly changing environment and demands.
    • Ability to interpret and effectively execute upon a variety of instructions provided in written, oral, diagram or schedule formats.

    Work Environment:

    Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; color vision; peripheral vision; ability to adjust focus.

    Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/or move up to 10 lbs.

    General: Moderate noise level, similar to typical office environment with computers, printers and light traffic.

    Qualified, interested candidates should send a resume to: admin@neximmune.com

  • Sr. Manager/Assoc. Director Regulatory Operations

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com

    Department: Regulatory

    Reports To: Chief Business Officer

    Status: Full Time/Exempt

    Position Summary:

    NexImmune is looking for a Sr. Manager or Associate Director of Regulatory Operations and Publishing to join our growing team. This role will be responsible for driving the process of developing and reviewing high quality, compliant IND submissions and additional applications for NexImmune’s Adoptive Cellular Therapy program. This position will require collaboration with all internal stakeholders and external partners to develop specific sections that form the basis of filing documents and to manage the e-submission development and submission process.

    Essential Duties and Responsibilities:

    • Lead development and publication of submission documents such as new applications, amendments, annual reports, etc. in eCTD compliant format and submit to the FDA via the Electronic Submissions Gateway (ESG) or other global regulatory agencies using an equivalent submission portal.
    • Coordinate publishing efforts across multiple key stakeholders.
    • Lead the development and filing of the IND.
    • Filing the Orphan Drug Applications and Priority Review Applications as appropriate.
    • Assist with the generation of XML documents as backbone for electronic submissions.
    • Assist in interpreting FDA and ICH guidance as related to the established eCTD templates and submission types (IND, DMF, Pre-Meeting Packages, Annual Report and BLA etc.)
    • Prepare documents for submission by scanning, rendering, bookmarking, and hyperlinking with supportive documents.
    • Perform quality review of documents for compliance to regulatory guidelines.
    • Maintain and track electronic submissions.
    • Assist with standard operating procedures (SOP) and working instruction (WI) creation, update, and maintenance
    • Perform additional Regulatory Affairs duties as requested.
    • Travel: Less than 20% is needed

    Education and Experience:

    • Bachelor’s degree in scientific discipline.

    Desired Key Competencies:

    • Three to five years of experience in regulatory filing for biologics at a minimum, cell therapy a plus; minimum of 1 year experience in eCTD Publishing and processing.
    • Solid knowledge of drug development, FDA, EMA and IHC guidelines and current Good Manufacturing Practices (cGMP)
    • Previous experience with early development programs through IND submission
    • Excellent organizational and communication skills both written and verbal.
    • Ability to work independently as well as in a team
    • Positive, energetic and proactive with ability to adapt rapidly to changing environment and demands.
    • Proven ability to identify and resolve regulatory issues
    • Self-organizer, meticulous hands-on habits, keen attention to detail.
    • Strong quantitative and analytical skills.
    • Responsive, can-do attitude.
    • Can coordinate parallel tasks across multiple projects, demonstrating prioritization.

    Qualified, interested candidates should send a resume to: admin@neximmune.com