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.

Montgomery County Ranked 4th Biopharma Centers in the Nation.

NexImmune fun in the lab
NexImmune Team
NexImmune serious in the lab
NexImmune working in the lab
  • Research Associate/Scientist I, Nanoparticle Platform Development

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com


    Department: Preclin Immunotherapy (PCI)
    Reports To: AD
    Status: Full Time/Exempt


    Position Summary:

    Research Associate / Scientist I will work closely with the AD of Nanoparticle Platform Development to translate and direct the company’s research strategy. He/she is expected to develop polymer and/or metal based nanoparticles (aAPC) that is the basis of our AIM 101 product, a direct injectable for treating Cancer, infectious diseases and autoimmune disease. He/she will synthesize and characterize nanoparticles, perform antibody/peptide conjugation, and test the final product in in vitro and in vivo assays. He/she will maintain high levels of laboratory skills, notebook recording/maintenance, and writing of reports in acceptable scientific format. He/she will be involved in data analysis and interpretation, writing and implementing SOP’s, and helping with other work as required by the company, thereby working closely with multiple teams.

    Essential Duties and Responsibilities:

    • Provide support for nanoparticle development for broad clinical applications
    • Perform nanoparticle synthesis, characterization, and conjugation techniques
    • Assist in developing new analytical methods
    • Provide inputs in research strategies
    • Assist in development of new nanoparticle platforms for evaluation and testing of new protein ligands
    • Write reports, protocols, SOP’s. Prepare data summaries and presentations.
    • Participate in Tech transfer and IND submissions

    Responsibility:

    • Supervisory: No
    • Travel: No

    Education and Experience:

    • M.S. or Ph.D. in Life science (Bio- or Chemical-Engineering, Biochemistry, or related field)
    • Experience in nanoparticle formulation techniques of polymers, metals, and lipids
    • Experience in protein coupling/conjugation techniques
    • Experience with analytical techniques including DLS, SEC, HPLC, chromatography columns
    • Experience with ELISA and other plate reader assays
    • Experience in writing data summaries and preparing scientific presentations
    • Demonstrated proficiency in Microsoft Office, including Word, Excel, and Power Point
    • Experience in Biotech Industry

    Desired Key Competencies:

    • Experience and knowledge of development of polymer based nanoformulations, targeted nanotherapeutics and device combinations for the delivery of antibodies, proteins and peptides
    • Synthesize and characterize biodegradable polymer nanoparticles for the delivery of anticancer drugs
    • Excellent communication skills
    • Self-motivated, independently minded, responsive with can-do attitude
    • 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
    • Background in Cancer Immunotherapy
    • 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.

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

  • Sr. Scientist Downstream Protein Process Development

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com


    Department: PD/MFG
    Reports To: VP, PD/MFG
    Status: Full Time/Exempt


    Position Summary:

    We are seeking candidates with extensive experience in developing, optimizing, and scaling up downstream processes from bench to pilot-scale; with preferably some experience working in cGMP manufacturing or regulated environment and/or a good understanding of regulatory/quality requirements.

    Qualified candidates will demonstrate a broad and current technical/scientific knowledge of downstream process development, optimization, and scale-up methodologies to develop robust and scalable production processes. Suitable candidates will have hands-on experience in all common chromatography separation (affinity, ion exchange, mixed mode, hydrophobic interaction) and filtration methods (depth, traditional/single-pass TFF, virus, sterile) as well as virus inactivation. Candidates with Bio-Rad NGC and/or GE AKTA experience and having basic protein analytical skills (HPLC and capillary electrophoresis or SDS-PAGE) are preferred. Candidates for the Senior Scientist position will demonstrate additional knowledge of, and preferably have experience with, DOE and statistical programs for design and analysis of experiments, QbD, scale-down model development and qualification, as well as process range/linkage/characterization/robustness studies.

    Candidates must have excellent technical writing skills and experience in preparing SOPs, protocols, technical reports, and/or batch records. Additional IND CMC and regulatory filing experience is a plus. Candidates must have good communication and interpersonal skills. Candidates must have a demonstrated ability to think critically, independently determine next steps, analyze and interpret data independently, design and execute appropriately controlled experiments, and maintain up-to-date laboratory notebooks.

    Qualifications:

    • B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 5 years biotech industry experience in downstream process development, optimization, and scale-up.
    • Experience with GE AKTA systems and protein analytical methods preferred.
    • Basic knowledge of GxP policies and procedures and regulatory requirements in the biotech industry
    • Knowledge of CMC regulatory requirements for biological pharmaceutical products, tech transfer and/or pilot- or large-scale cGMP manufacturing a plus.
    • Senior level candidates should have knowledge of statistical tools and DoE (incl software), QbD principles, and/or with scale-down model development/qualification, process range, linkage, and/or process characterization studies.
    • Proficient with the use of MS Office software (Word, Excel, Power Point) and Unicorn software.
    • Excellent problem solving, organizational, and time management skills
    • Must demonstrate initiative and be self-motivated
    • Must have excellent communication and writing skills
    • Positive attitude and interpersonal skills and the ability to work in team-oriented environment are essential
    • Plan, design, execute, and record experiments using good scientific principles and with keen attention to detail.
    • Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
    • Can coordinate and prioritize parallel tasks
    • Must be flexible and able to adapt to changing demands.

    Responsibilities:

    • Develop, optimize, and scale up robust and efficient purification process for pilot production and subsequent cGMP manufacturing of Phase I candidates.
    • Screen different resins and filters systemically and then conduct follow-on optimization, process range finding, and robustness studies to optimize protein yield and purity.
    • Perform experiments using Bio-Rad NGC and GE AKTA chromatography systems, conventional and single-pass TFF systems, and industry standard filtration (harvest, sterile, viral) methods at bench and pilot-scale.
    • Participate in transfer of downstream processes to in-house pilot GMP production suite or external CMOs.
    • Perform standard in-process analytical techniques including HPLC, SDS-PAGE/CE, and protein assays.
    • Organize, interpret, analyze, and present results in clear, concise fashion.
    • Write development reports (progress, summary, tech transfer), protocols, and SOPs.
    • Draft production batch records for GMP manufacturing, support and troubleshooting GMP production activities
    • Maintain up-to-date GLP compliant lab notebook.

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

  • Sr. Scientist Upstream Process Development

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com


    Department: PD/MFG
    Reports To: VP, PD/MFG
    Status: Full Time/Exempt


    Position Summary:

    We are seeking candidates with extensive experience in developing, optimizing, and scaling up cell culture processes from bench to pilot-scale; with preferably some experience with cGMP manufacturing and knowledge of regulations preferred.

    Qualified candidates will demonstrate a broad and current technical/scientific knowledge of cell culture process development, optimization, and scale-up methodologies to develop robust, scalable, high-titer cell culture processes. Suitable candidates will have hands-on experience working with different mammalian expression systems, shaker and spinner flask cultures, conventional and single-use bioreactor systems, and have a thorough understanding of cell culture laboratory techniques and practices. Suitable candidates will have experience conducting media screening and feed strategy optimization studies as well as studies to identify and determine appropriate ranges of (critical) process parameters to optimize cell growth and productivity. Candidates should have a thorough understanding of current FDA and ICH guidelines regarding cell culture drug substance processes. Candidates for the Senior Scientist position will demonstrate additional knowledge of, and preferably have experience with, statistical tools, DOE (and software) and QbD principles as well as process range finding and characterization studies.

    Candidates must have excellent technical writing skills with experience in preparing SOPs, protocols, technical reports, and/or batch records. Additional IND CMC and regulatory filing experience is a plus. Candidates must have good communication and interpersonal skills. Candidates must have a demonstrated ability to think critically, analyze and interpret data independently,

    Qualifications:

    • B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 5 years biotech industry experience in cell culture process development, optimization, and scale-up.
    • Hands-on experience in upstream laboratory activities including the operation of mini/bench to pilot scale bioreactor systems.
    • Knowledge of bioreactor characterization and engineering principles as well as robust understanding of biochemistry and cell metabolic pathways.
    • Knowledge of CMC regulatory requirements for biological pharmaceutical products, tech transfer and/or pilot- or large-scale cGMP manufacturing a plus.
    • Senior level candidates should have knowledge of statistical tools and DoE (incl software) principles as well as basic process range finding and characterization studies.
    • Proficient with the use of MS Office software (Word, Excel, Power Point).
    • Excellent problem solving, organizational, and time management skills
    • Must demonstrate initiative and be self-motivated
    • Must have excellent communication and writing skills
    • Positive attitude and interpersonal skills and the ability to work in team-oriented environment are essential
    • Plan, design, execute, and record experiments using good scientific principles and with keen attention to detail.
    • Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
    • Can coordinate and prioritize parallel tasks.
    • Must be flexible and able to adapt to changing demands.

    Responsibilities:

    • Develop, optimize, and scale up robust and high-yield cell culture fed-batch processes for pilot production and subsequent cGMP manufacturing of Phase I candidates.
    • Characterize cell lines and evaluate cell line stability and suitability for pilot/GMP manufacture.
    • Use DOE and other scientific methods to determine optimal growth parameters, media formulations, and feed strategies in small-scale shakers and bioreactors.
    • Participate in transfer of cell culture processes to in-house pilot GMP production suite or external CMOs.
    • Organize, interpret, analyze, and present results in clear, concise fashion.
    • Participate in transfer of downstream processes to in-house pilot GMP production suite or external CMOs.
    • Write development reports (progress, summary, tech transfer), protocols, and SOPs.
    • Draft production batch records for GMP manufacturing, support and troubleshooting GMP production activities
    • Maintain up-to-date GLP compliant lab notebook.

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

  • Sr. Clinical Program Manager/Director, Clinical Operations

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com


    Department: Clinical
    Reports To: Vice-President, Clinical Development
    Status: Full Time/Exempt


    Position Summary:

    Independently plans and manages overall clinical operations for assigned clinical trial(s)/program(s) including, timelines, budgets, resources, investigational sites, vendors and key project deliverables in compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and in alignment with Therapeutic Area (TA) strategies and goals. This position provides clinical project management expertise and leads a cross-functional team through all aspects of design, planning, start-up, conduct, analysis, reporting and close-out of assigned clinical trials. Provides matrix management of functional area representatives to cross-functional study teams.

    Essential Duties and Responsibilities:

    • Overall clinical trials execution within study budgets and timelines.
    • Provide clinical trials operational and strategic input to internal team members/vendors, which include clinical planning tools, protocol development, CRF development, IRB submissions, investigator agreements, ICF development, Investigator selection, clinical trial operational manuals, training materials, and various clinical trial plans, site selection and budget planning.
    • Oversee and direct internal team members/vendors on clinical monitoring and site activities to ensure compliance with Good Clinical Practices (GCP) and applicable regulations. Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) to ensure integrity, accuracy and accountability of clinical data. Informs on overall clinical trial status and of potential issues/mitigation. Participate for on-site visits as needed.
    • Develop study specific processes for internal team members/vendors to communicate with clinical trial sites regarding all logistics including contracts, clinical trials support materials and training and regulatory application process. Oversee set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance. Develop study training for study team, investigational sites, and vendors. Develop and oversees clinical site budgets, investigator payment processes and invoices related to projects assigned.
    • Key decision maker in the selection of clinical service provider personnel including contractors, and clinical research organizations, and with specification development, and management/oversight of any internal/external personnel. Serves as the primary project contact for communication and coordination for the vendors. Oversee monitoring trip reports process and ensure resolution of all action items related to CROs. Ensure that vendors comply with all required standards and raises any issues and/or concerns. Oversee site contract and budget preparation, negotiations and management throughout the trial life cycle.
    • Facilitate clinical study team meetings that comprise of internal or vendor cross functional representation. Ensure that study information is disseminated to the appropriate parties.
    • Oversee data review of clinical data listings (protocol deviations, focused study data review, etc.) for completeness and accuracy and escalate issues as needed. Implement corrective actions to avoid or mitigate problems to balance study deliverables and costs.
    • Ensure that the study regulatory files are collected and filed in the Trial Master File.
    • Ensure study teams & clinical sites have the appropriate study management tools to execute the study.
    • Act as a key contributor to the Clinical Operations department to include initiatives to improve processes & SOP development.
    • Represents Clinical Operations in cross-functional initiatives and provide input into non-project related activities and development of department processes

    Responsibility:

    • Supervisory: None, initially
    • Travel: To meetings, sites and vendors approximately 10 – 20%

    Education and Experience:

    • Bachelor’s degree in a relevant scientific discipline
    • Minimum of 8 years of clinical research experience, at least 3 of which are as a Project Manager for clinical studies at a CRO and/or pharma/biotech organization
    • Previous experience negotiating vendor/site contracts and budget management
    • Thorough understanding of FDA, ICH and GCP guidelines
    • Experience with Early Phase and Registrational clinical trials
    • Proven track record showing clear proficiency in clinical project management skills
    • Proven complex problem-solving skills
    • Solid vendor management skills, e.g. CRO, Laboratory & Clinical supply logistics
    • Broad understanding of clinical operations related to clinical development functions
    • Detailed understanding of all aspects of clinical protocol design, implementation & overall development
    • Ability to effectively interface with medical personnel at clinical site(s)
    • Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent forms, and other study-related documents
    • Detail and team-oriented with excellent cross-functional team leadership and participation skills
    • Proficiency with computer programs including Microsoft Office suite and Microsoft Project

    Desired Key Competencies:

    • Excellent communication skills. Excellent interpersonal, verbal and written communication skills are essential in this small company and collaborative work environment
    • Self motivated and independently minded.
    • Positive interpersonal skills with the ability to interact with individuals, teams and vendors
    • Self-organizer, meticulous hands-on habits, keen attention to detail.
    • Strong quantitative and analytical skills.
    • Responsive and 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

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

  • Sr. Facilities Technician

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com


    Department: Operations
    Reports To: Director of Operations
    Status: F/T


    Position Summary:

    The Sr. Facility Technician will act as a key contributor for our NexImmune Team. The position will function as overall building support in the facilities arena to accommodate our current needs as a growing company. This is a. skilled position responsible for both predictive and preventive maintenance of all building and lab equipment/systems. The individual must have a diversified background in GMP process equipment/systems, as well as industrial equipment repair and maintenance.

    Essential Duties and Responsibilities:

    • Provide technical/mechanical support on all process equipment/systems for the operations and supporting utilities.
    • Performs work in one or more maintenance trades including, electrical, plumbing and HVAC
    • Performs routine equipment repair and installation of office fixtures and moves.
    • Responsible for mechanical service calls and in-house repairs throughout facility and grounds.
    • Diagnose, repair and service equipment/systems which can include but not limited to RODI, WFI, boilers, chillers, Biowaste System, Clean Steam System, HVAC, BMS, Compressed Gases. May also, include Laboratory equipment HPLCs Plate washers various other laboratory instruments, pump seals / rebuilds, plumbing/piping work, etc.
    • Execute and review preventive and corrective work orders as scheduled and ensure timely closure of work orders.
    • Requires supervision of outside contractors performing facility and equipment related services.
    • Requires supervision of contractors to remodel labs and offices
    • Respond to building alarms and/or equipment/system alarms during normal business hours and/or off hours.
    • The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

    Responsibility:

    • Supervisory: None

    Education and Experience:

    • Minimum of High School degree and/or 8-10 years of experience in the field of pharmaceutical/biotechnology (or equivalent).
    • Sufficient experience in the facility/equipment/system maintenance in the biotechnology/pharmaceutical industry.
    • This position requires a mechanic with multiple craft experience in the maintenance and repair of manufacturing equipment as to it pertains to biological processes and systems.
    • Must have considerable experience in the troubleshooting of complex and specialized equipment consisting of process specific, utility, refrigeration and environmental control systems.

    Desired Key Competencies:

    • Minimum of High School degree and/or 8-10 years of experience in the field of pharmaceutical/biotechnology (or equivalent).
    • Sufficient experience in the facility/equipment/system maintenance in the biotechnology/pharmaceutical industry.
    • This position requires a mechanic with multiple craft experience in the maintenance and repair of manufacturing equipment as to it pertains to biological processes and systems.
    • Must have considerable experience in the troubleshooting of complex and specialized equipment consisting of process specific, utility, refrigeration and environmental control systems.

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