Careers:Adventurers Wanted

Want to contribute to the advancement of the next generation of T cell therapies that will revitalize lives? At NexImmune, we are seeking to develop therapies that will change the way cancer is treated by restoring the body’s natural immunity. We’re assembling a team of individuals that are paving the road toward that destination. Join us in this critical journey.

We are a clinical-stage biopharmaceutical company applying our proprietary Artificial Immune Modulation (AIM™) nanotechnology platform to develop T cell-based immunotherapies with the potential to cure a broad range of 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. We focus on setting clear expectations, empowering people to succeed, and rewarding results.

Benefits include:

  • Competitive salaries with discretionary annual bonus
  • 401(k) retirement plan with company match
  • Health Dental & Vision plans
  • Paid vacation, Sick and Personal Days
  • Opportunities to participate in equity ownership
  • Tuition Reimbursement & Professional Development
  • Parental Leave
  • Employee Referral Program

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 among biopharma clusters in the U.S.

Core Values

  • Fiercely Innovative
  • Sense of Community
  • Humble Determination
  • Decisions with Integrity
  • Trust & Respect
  • Urgency
  • Empowered Accountability

Join Our Team: Open Positions

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Manufacturing
Reports To: Chief Operating Officer
Status: Full Time / Exempt

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology. 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 a company with an uncompromising commitment to shared values, a strong work ethic, and respect for individuals. We set clear expectations, empower people to succeed, and reward results. Our executive team, Board of Directors, and investors include several successful industry veterans committed to building an exceptional company capable of transforming the field of immunotherapy.

The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIMTM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. By mimicking natural T cell biology, NexImmune’s T cell product candidates are designed to combine the attributes of cellular precision, potency, and persistence with reduced potential for undesired toxicities.

NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

For more information, visit www.neximmune.com.

Position Summary:

NexImmune seeks a dynamic, experienced leader with an entrepreneurial spirit to join the NexImmune team. We are looking for qualified candidates with a Masters or Ph.D. degree in the life sciences or biochemical engineering with over 15 years experience in the biotech industry to build internal process development capabilities and to lead the initial downstream process development and cGMP manufacture of recombinant antibody development of two lead proteins. The role will streamline the path for additional future product candidates including other HLA subtypes, co-stimulatory molecules and molecules needed for highly customized assays to support the AIM platform.

Candidates MUST have significant experience in upstream and downstream protein manufacture and process development including hands-on laboratory and manufacturing experience. The ideal individual will be a protein manufacturing process expert with a track record in the biotech community, with emphasis on antibody and/or related protein production. Candidates must also be familiar with manufacturing document preparation and reporting data for the IND process. Excellent communication skills, including preparation and delivery of oral and written presentations and reports are important. Candidates must have a demonstrated ability to think citically, analyze and interpret data, design appropriately controlled experiments, as well as provide oversight of key personnel..

As the company continues to grow and evolve, this role will continue to build out this and new capabilities to ensure rapid , successful candidate selection and translatable process development of new molecules. This core function will streamline and accelerate rapid platform development.

Essential Duties and Responsibilities:

  • Build and manage Process Development group
  • Lead process development activities for lead product candidates
  • Purify proprietary proteins from mid- to large scale volumes.
  • Recruit, train and develop talent
  • Provide technical guidance and coordinate with CRO/CMO for tech transfer of developed process
  • Establish and develop solid documentation systems including writing reports
  • Adopt and develop new process development technologies
  • Responsible for planning and budgeting for group
  • Work with C-level and senior management team towards achieving strategic company goals
  • Comply with company’s policies and procedures
  • Perform other duties as assigned

Education and Experience:

  • M.S. or PhD. in life sciences or biochemical engineering with 15 plus years experience in the biotech industry with at least 10 years hands on laboratory experience in process development as well as cGMP manufacturing experience.
  • Strong scientific background with demonstrated strong written and verbal communication skills
  • Essential skills: experience with antibody discovery/development
  • Hands on experience in translational, pilot and large scale protein manufacture, process design and development

Desired Key Competencies:

  • Excellent time management and proven ability to deliver
  • Excellent level of initiative and quest for knowledge
  • Must be organized and self-motivated
  • Must have excellent communication and writing skills
  • 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.
  • Can coordinate parallel tasks across multiple projects, demonstrating prioritization.
  • Ability to quickly adapt to a rapidly changing environment and demands.

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 20 lbs

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

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Finance
Reports To: CFO
Status: Exempt

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology. 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 a company with an uncompromising commitment to shared values, a strong work ethic, and respect for individuals. We set clear expectations, empower people to succeed, and reward results. Our executive team, Board of Directors, and investors include several successful industry veterans committed to building an exceptional company capable of transforming the field of immunotherapy.

The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIMTM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. By mimicking natural T cell biology, NexImmune’s T cell product candidates are designed to combine the attributes of cellular precision, potency, and persistence with reduced potential for undesired toxicities.

NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

For more information, visit www.neximmune.com.

Position Summary:

The Controller position is essential to the effective operations of the company.  This position ensures the effectiveness of the financial control environment and the accounting policies, processes and procedures of the organization. This position will ensure that the accounting for all transactions is performed in an accurate, efficient and timely manner in conformity with GAAP.  The Controller works cross-functionally with leaders (including as part of the budgeting management process), is primarily responsible for managing the company’s public filings, and reports directly to the Chief Financial Officer.

Essential Duties and Responsibilities:

  • All accounting operations and full cycle transactional responsibilities including, but not limited to, the following:
    • Cash Management
    • Accounts Receivables / Customer Maintenance
    • Prepaids
    • Fixed Assets
    • Capital Leasing
    • Accounts Payable / Vendor Maintenance
    • Purchasing and Requisitioning
    • General Ledger / Chart of Accounts / Journal Entries
    • Invoicing/Billing
    • Revenue recognition in conformity with ASC 606
    • Expenses
  • Team management and leadership (expect to manage a team of 2-4 persons)
  • Responsible for supervising and signing off on the semi-monthly payrolls for all employees
  • Ownership over the monthly, quarterly and annual close cycle (close, consolidation and reporting), including the preparation or review of all supporting documentation, schedules, reconciliations and other requirements for appropriate regulatory filing (e.g., 10-Q and 10-K forms) with the SEC.
  • Has primary ownership of the annual audit and interim reviews, coordinates with outside auditors and manages internal resources to complete on an accurate and timely basis.
  • Coordinates the timely filing of the Company tax returns prepared by outside tax advisors and ensures proper maintenance of accounting records and documentation in compliance with statutory requirements and Company policies.
  • Directs the preparation and analysis of monthly financial statements for review by Company management
  • Oversees company sub-contractors, consultants and vendors relative to invoices, purchase orders and certificates of insurance.
  • Support the business and management with accurate cost accounting and department profit & loss statements.
  • Lead the company’s efforts to achieve full compliance with Sarbanes-Oxley regulations.
  • Pricing, cost and other strategic modeling and analytics.
  • Perform other duties as assigned and / or required.

Education and Experience:

  • Bachelor’s degree in Accounting required
  • CPA certification required
  • Minimum of 3+ years of experience in public accounting
  • Minimum 2 years of experience working in the finance department of a publicly-traded company
  • Experience with Sarbanes-Oxley and SEC reporting requirements
  • Experience with stock-based compensation and equity mechanisms
  • Experience in biotechnology / pharmaceutical industry preferred
  • Working knowledge of Sage Intacct system preferred

Desired Key Competencies:

  • Collaborative team player
  • High level verbal and written communications skills
  • Ability to gather and analyze information skillfully
  • Thorough and high attention to detail
  • Expertise in accounting in accordance with GAAP
  • Exemplary planning and time management skills
  • Ability to multitask and prioritize daily workload
  • Discretion and confidentiality
  • Ability to work with cross-functional teams and senior finance management
  • Demonstrated ability to mentor and train personnel

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 20 lbs

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

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Molecular Engineering
Reports To: Senior Vice President
Status: Full Time/Exempt

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology. 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 a company with an uncompromising commitment to shared values, a strong work ethic, and respect for individuals. We set clear expectations, empower people to succeed, and reward results. Our executive team, Board of Directors, and investors include several successful industry veterans committed to building an exceptional company capable of transforming the field of immunotherapy.

The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIMTM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. By mimicking natural T cell biology, NexImmune’s T cell product candidates are designed to combine the attributes of cellular precision, potency, and persistence with reduced potential for undesired toxicities.

NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

For more information, visit www.neximmune.com.

Position Summary:

NexImmune is seeking highly motivated applicants with an entrepreneurial spirit for an open position in our Molecular Engineering department. We are seeking qualified candidates with a Masters or Ph.D. degree in the life sciences. Candidates must be broadly trained in molecular biology techniques, including protein design and engineering, DNA sequence analysis, molecular cloning, genome engineering, cell line development, protein expression and purification.  Knowledge of transposon- and lenti-based expression systems is desirable. Experience with common research-scale protein purification techniques and equipment, such as FPLC (AKTA or BioRad) is essential. Knowledge of multiple protein expression systems is desired, with an emphasis on CHO and insect cell lines.  The candidate must have deep understanding of diverse analytical techniques, including ELISA, SDS-PAGE, qRT-PCR, HPLC, and Octet.

Essential Duties and Responsibilities:

  • Take lead role for protein engineering and cell line development activities, including management of 1+ direct report
  • Oversee the development of cell lines for production of a diverse set of biological molecules
  • Design, build, purify, and test proprietary proteins from small to medium scale volumes
  • Manage time and use of bioanalytical and purification instrumentation
  • Directly interact with counterparts in contract manufacturing organizations and affiliates
  • Order supplies and reagents, maintain inventory records
  • Write reports and protocols

Education and Experience:

  • M.S. or Ph.D. in life sciences field.
  • Hands on experience in protein manufacture and process development
  • Excellent time management and proven ability to complete projects on time
  • Excellent level of initiative and quest for knowledge
  • Demonstrated proficiency in Microsoft Office, including Word, Excel, and PowerPoint.

Desired Key Competencies:

  • Must be organized and self-motivated
  • Must have excellent communication and writing
  • 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.
  • 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 20 lbs

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

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Molecular Engineering
Reports To: Senior Vice President
Status: Full Time/Exempt

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology. 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 a company with an uncompromising commitment to shared values, a strong work ethic, and respect for individuals. We set clear expectations, empower people to succeed, and reward results. Our executive team, Board of Directors, and investors include several successful industry veterans committed to building an exceptional company capable of transforming the field of immunotherapy.

The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIMTM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. By mimicking natural T cell biology, NexImmune’s T cell product candidates are designed to combine the attributes of cellular precision, potency, and persistence with reduced potential for undesired toxicities.

NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

For more information, visit www.neximmune.com.

Position Summary:

The Scientist I / Senior Scientist will act as a scientific contributor for the Molecular Engineering department’s support of the development of novel nanoparticles, artificial antigen presenting cell (aAPC), based upon NexImmune’s proprietary aAPC technologies. The focus of this role will revolve around cell line development, particularly using CHO and K562 cell lines, for use in protein expression and cell-base bioassays. Experience with protein expression in insect cell systems is also desirable. Expertise in molecular cloning tools and techniques are required. The candidate will support additional tissue culture activities as needed and will be responsible for coordination and transfer of cell lines to other groups for further analysis and development. Such cell lines will be pivotal for the cGMP manufacture of key signaling proteins for the preparation of aAPCs.  Standard molecular biology laboratory skills, notebook recording/maintenance, and writing of reports in acceptable scientific format(s) are required.

Essential Duties and Responsibilities:

  • Assist in the culture of mammalian cell lines
  • Assist in molecular cloning and analysis of plasmid-based protein expression vectors
  • Preparation and transfection of plasmid DNA into mammalian cells, particularly in CHO cell systems
  • Perform the selection of stable CHO cell line pools and clones utilizing published and/or commercially available systems
  • Isolation and characterization of clonal expression cell lines
  • Insect cell and baculovirus culture
  • Assist in protein purification and analysis activities
  • Order supplies and reagents and maintain inventory records
  • Write reports, protocols, and SOPs

Education and Experience:

  • Masters or PhD in Molecular Biology, Cell Biology or related field.
  • Experience working in mammalian cell culture with emphasis on the establishment of stable CHO cell lines and documentation for cGMP qualification.
  • Experience in clonal cell line isolation by limiting dilution, single cell printing, or automated clone isolation equipment
  • Familiar with writing batch record files, capturing relevant data, and presentation of data to the team and Senior Management.
  • 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 20 lbs

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

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

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

 

Position Summary:

The Scientist/Sr. 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:

  • T cell cloning
  • Assay development and validation
  • Isolation and expansion of Antigen-specific T cells
  • FACS analysis and sorting
  • Perform Cytokine and killing assays
  • Perform ELISA and protein assays
  • Order supplies and reagents, maintain inventory records
  • Write reports, protocols and SOPs

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

 

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Protein Development and Manufacturing
Reports To: VP, PD/MFG
Status: Full Time/Exempt

 

Position Summary:

We are seeking Scientist candidates with extensive biotech industry experience in developing, optimizing, and scaling up cell culture manufacturing processes from bench to pilot-scale production (preferably cGMP manufacturing).

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, single-use bioreactor systems, and have a thorough understanding of cell culture laboratory techniques and practices. Suitable candidates should have experience conducting cell line stability studies and establishing suitable process scale-down models. Candidates will need to demonstrate extensive experience conducting media screening, feed strategy, and bioreactor process parameter optimization studies to optimize cell growth and productivity.

Candidates must have excellent communication and writing skills, with extensive experience preparing technical documents (e.g. SOPs, protocols, technical reports, and/or batch records). Candidates must have a demonstrated ability to work independently, design and execute appropriately controlled experiments, analyze and interpret data critically, 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 of biotech industry experience in cell culture process development, optimization, and scale-up.
  • Basic knowledge of GxP guidelines for the biotech industry
  • Robust understanding of cellular biochemistry and metabolic pathways.
  • Hands-on experience with spinner and shaker culture, and mini/bench to pilot scale bioreactor systems.
  • Tech transfer and/or pilot- or large-scale cGMP manufacturing experience a plus.
  • 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
  • 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:

  • Plan, design, execute, and record experiments, and independently analyze results using good scientific principles and with keen attention to detail and quality. Maintain an up-to-date GLP compliant lab notebook.
  • 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 or other scientific methods to determine optimal growth parameters, media formulations, and feed strategies in small-scale shakers and mini-bioreactors.
  • Participate in transfer of cell culture processes to in-house pilot GMP production suite (or CMO if required) and conduct engineering and cGMP pilot manufacturing runs.
  • Write development reports (progress, summary, tech transfer), protocols, and SOPs.
  • Support drafting and/or revisions of production batch records for cGMP manufacturing as well as close-out of executed batch records with QA.

 

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Protein Development and Manufacturing
Reports To: VP, PD/MFG
Status: Full Time/Exempt

 

Position Summary:

We are seeking Senior Scientist candidates with extensive biotech industry experience in developing, optimizing, and scaling up downstream manufacturing processes from bench to pilot-scale production (preferably cGMP manufacturing).

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 (detergent, low pH). Candidates with Bio-Rad NGC and/or GE AKTA experience and with basic protein analytical skills (HPLC and capillary electrophoresis or SDS-PAGE) are preferred.

In addition to the above, candidates for the Senior Scientist position will demonstrate additional working knowledge in one or more of the following: DOE and statistical tools for design and analysis of experiments, QbD principles, scale-down model development and qualification, as well as process linkage and characterization studies. Senior scientist candidates should also have a good working understanding of current FDA and ICH guidelines and preferably have some IND CMC and regulatory filing experience.

Candidates must have excellent communication and writing skills, with extensive experience preparing technical documents (e.g. SOPs, protocols, technical reports, and/or batch records). Candidates must have a demonstrated ability to work independently, design and execute appropriately controlled experiments, analyze and interpret data critically, 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 10 years of biotech industry experience in downstream process development, optimization, and scale-up.
  • Basic knowledge of GxP guidelines for the biotech industry
  • Experience with BioRad NGC and/or GE AKTA systems and protein analytical methods preferred.
  • Extensive working knowledge of all common chromatography and filtration methodologies.
  • Tech transfer and/or pilot- or large-scale cGMP manufacturing experience a plus.
  • 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
  • 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.
  • Senior Scientist position will demonstrate working knowledge in or more of the following: statistical tools and DOE, QbD principles, process characterization studies, FDA and ICH guidelines, IND and/or regulatory (CMC) filing experience.

Responsibilities:

  • Plan, design, execute, and record experiments, and independently analyze results using good scientific principles and with keen attention to detail and quality. Maintain up-to-date GLP compliant lab notebook.
  • 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 CMO if required) and conduct engineering and cGMP pilot manufacturing runs.
  • Perform standard in-process analytical techniques including HPLC, SDS-PAGE/CE, and protein assays.
  • Write development reports (progress, summary, tech transfer), protocols, and SOPs.
  • Support drafting and/or revisions of production batch records for cGMP manufacturing as well as close-out of executed batch records with QA.

 

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Protein Development and Manufacturing
Reports To: VP, PD/MFG
Status: Full Time/Exempt

 

Position Summary:

We are seeking Scientist candidates with extensive biotech industry experience in developing, optimizing, and scaling up downstream manufacturing processes from bench to pilot-scale production (preferably cGMP manufacturing).

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 (detergent, low pH). Candidates with Bio-Rad NGC and/or GE AKTA experience and with basic protein analytical skills (HPLC and capillary electrophoresis or SDS-PAGE) are preferred.

Candidates must have excellent communication and writing skills, with extensive experience preparing technical documents (e.g. SOPs, protocols, technical reports, and/or batch records). Candidates must have a demonstrated ability to work independently, design and execute appropriately controlled experiments, analyze and interpret data critically, 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 of biotech industry experience in downstream process development, optimization, and scale-up.
  • Basic knowledge of GxP guidelines for the biotech industry
  • Experience with Biorad NGC and/or GE AKTA systems and protein analytical methods preferred.
  • Extensive working knowledge of all common chromatography and filtration methodologies.
  • Tech transfer and/or pilot- or large-scale cGMP manufacturing experience a plus.
  • 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
  • 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:

  • Plan, design, execute, and record experiments, and independently analyze results using good scientific principles and with keen attention to detail and quality. Maintain up-to-date GLP compliant lab notebook.
  • 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 CMO if required) and conduct engineering and cGMP pilot manufacturing runs.
  • Perform standard in-process analytical techniques including HPLC, SDS-PAGE/CE, and protein assays.
  • Write development reports (progress, summary, tech transfer), protocols, and SOPs.
  • Support drafting and/or revisions of production batch records for cGMP manufacturing as well as close-out of executed batch records with QA.

 

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

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

 

Position Summary:

The Research Associate/ Senior Research Associate 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 and protein assays
  • Order supplies and reagents, maintain inventory records
  • Write reports, protocols and SOPs

Education and Experience:

  • BA or MS in Life science (Immunology, Biology, Biochemistry, Biochemistry, or related field) with 1-3 years of hands-on experience in industry
  • Experience in Immunology and T cell biology
  • Experience working in mammalian cell culture, sterile techniques
  • Experience with FACS and panel design
  • Experience ELISA and other plate reader assays
  • Experience with handling clinical samples
  • Demonstrated proficiency in FlowJo, GraphPad Prism, and Microsoft Office, including Word, Excel, 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

 

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Finance
Reports To: CFO
Status: Full Time/Exempt

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology. 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 a company with an uncompromising commitment to shared values, a strong work ethic, and respect for individuals. We set clear expectations, empower people to succeed, and reward results. Our executive team, Board of Directors, and investors include several successful industry veterans committed to building an exceptional company capable of transforming the field of immunotherapy.

The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIMTM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. By mimicking natural T cell biology, NexImmune’s T cell product candidates are designed to combine the attributes of cellular precision, potency, and persistence with reduced potential for undesired toxicities.
NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.
For more information, visit www.neximmune.com.

Position Summary:

NexImmune is looking for a Senior Director of Business Development. This person will lead the company’s work in establishing strategic partnerships via outlicensing and collaborations, as well as other scientific and corporate alliances as needed. For an early-stage company like NexImmune, these alliances are critical to the company’s strategy and growth and this person will have significant visibility across the company and with the Board. This person’s responsibilities will include developing partnering strategies, targeting key potential partners and building / maintaining relationships with those partners, structuring and negotiating partnerships and preparing and delivering presentations to the management and Board integrating and summarizing relevant scientific, clinical, financial, and market information.

Essential Duties and Responsibilities:

  • Establish and implement appropriate business development strategies to support company’s strategic growth goals.
  • Establish new scientific and strategic partnerships, joint ventures and alliances in collaboration with the company’s R&D organization.
  • Follow-up on all partnership activity including the tracking, documentation and status reporting of all collaborations along the business development pipeline.
  • Direct the assessment of future markets and licensing potential, and be responsible for coordinating / quality-checking input across internal groups to support such assessments.
  • Interact with existing corporate contacts, facilitate communication, keep track of milestones and identify opportunities to enhance the scope of these relationships.
  • Manage the development of the business case and financial model with other internal functions, and project manage the overall assessment of interesting opportunities
  • Prepare and deliver presentations to management team and Board integrating and summarizing scientific, clinical, financial, and market information
  • Structure and negotiate terms of licensing agreements with potential business partners. In many cases you will work independently and play a lead negotiation role.
  • Participate in or lead other internal strategic initiatives.

Education and Experience:

  • 5+ years of BD / licensing experience (out-licensing experience preferred) in the biotechnology and/or pharmaceutical industry.
  • Must have conducted negotiations of deals with a certain level of complexity in terms of contract structure, project team interactions and approval processes.
  • Self-starter, self-motivated and outgoing, with the ability to lead multi-disciplinary teams without direct authority over the team members. Is articulate, persuasive and convincing.
  • Goal-oriented and able to drive and deliver a project through all of its complex and challenging stages whilst meeting externally and internally defined deadlines.
  • Self-confident, can interact at high level and be able to brief senior executives in a clear and concise manner. Able to work independently and as part of a team.
  • An individual of high personal and business integrity and ethics with uncompromising standards; ability to quickly establish trust.
  • Medical and/or scientific education ideal; MBA a plus.
  • Ability to build and maintain contacts with potential partner companies.

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Pre-Clinical
Reports To: AD, Nano Platform Development
Status: Exempt

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology. 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 a company with an uncompromising commitment to shared values, a strong work ethic, and respect for individuals. We set clear expectations, empower people to succeed, and reward results. Our executive team, Board of Directors, and investors include several successful industry veterans committed to building an exceptional company capable of transforming the field of immunotherapy.

The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIMTM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. By mimicking natural T cell biology, NexImmune’s T cell product candidates are designed to combine the attributes of cellular precision, potency, and persistence with reduced potential for undesired toxicities.

NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.
For more information, visit www.neximmune.com.

Position Summary:

Scientist I will act as a scientific contributor for the Preclinical Immunotherapy and Nanoparticle Platform Development department to translate and direct the company’s research strategy in developing novel nanoparticle-based immunotherapies. The candidate is expected to develop polymer-, metal- and lipid-based nanoparticles based on company’s proprietary artificial antigen presenting cell (aAPC) technologies to treat cancers, infectious diseases, and autoimmune diseases. The candidate will develop methods to synthesize and characterize nanoparticles, to conjugate antibodies, and to test the final product in in vitro and in vivo assays. The candidate will be responsible for nanoparticle purification techniques using SEC/TFFF. 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 SOPs, 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 nanoparticle purification/separation methods using SEC and/or TFFF
  • Assist in development of new nanoparticle platforms for evaluation and testing of new protein ligands and peptide antigens
  • Provide inputs in research strategies
  • Write reports, protocols, SOPs. Prepare data summaries and presentations.
  • Participate in Tech transfer and IND submissions

Education and Experience:

  • 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, ELISA and protein assay
  • Experience in writing data summaries and preparing scientific presentations
  • Experience in cell culture and cell-based assays

Desired Key Competencies:

  • Experience and knowledge of development of nanoparticle-based formulations for the delivery of antibodies, proteins and peptides
  • Experience and knowledge of nanoparticle fractionation/purification using SEC/TFFF
  • Self-motivated, independently minded, responsive with can-do attitude
  • Positive interpersonal skills with the ability to interact with individuals from a variety of levels/functions
  • Self-organizer, meticulous hands-on habits, keen attention to detail
  • Strong quantitative and analytical skills
  • 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: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Pre-Clinical
Reports To: AD, Nano Platform Development
Status: Exempt

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology. 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 a company with an uncompromising commitment to shared values, a strong work ethic, and respect for individuals. We set clear expectations, empower people to succeed, and reward results. Our executive team, Board of Directors, and investors include several successful industry veterans committed to building an exceptional company capable of transforming the field of immunotherapy.

The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIMTM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. By mimicking natural T cell biology, NexImmune’s T cell product candidates are designed to combine the attributes of cellular precision, potency, and persistence with reduced potential for undesired toxicities.

NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.
For more information, visit www.neximmune.com.

Position Summary:

The Scientist I / Senior Scientist in preclinical nano-immunotherapy will act as a scientific contributor for developing and optimizing a new clinical approach to treat autoimmune diseases, based upon NexImmune’s proprietary artificial Antigen Presenting Cell (aAPC) technologies. The candidate will assist in the formulation of nanoparticle-based aAPC, characterization and functional assessment of aAPC and antigen-specific T cells. Laboratory skills, notebook recording/maintenance, and writing of reports in acceptable scientific format(s) are important. He/she will be involved in data analysis and interpretation, writing and implementing SOPs, 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 cell culture of mammalian and animal cell line
  • Isolation and expansion of antigen-specific T cells
  • FACS analysis
  • Perform ELISA, protein assays, cell-based assays, and nanoparticle-based assays
  • Assay development and validation
  • Write reports, protocols, SOPs. Prepare data summaries and presentations.
  • Order supplies and reagents, maintain inventory records

Education and Experience:

  • MS or PhD in Life science (Immunology, Biology, Biochemistry or related field)
  • Experience in immunology, T cell biology, autoimmune biology
  • Experience with mammalian and animal cell culture, sterile techniques
  • Experience with FACS, panel design, and FlowJo
  • Experience with ELISA, protein assays, and other plate reader-based assays
  • Experience with mouse models for autoimmune diseases
  • Experience in writing data summaries and preparing scientific presentations
  • Demonstrated proficiency in GraphPad Prism, MS Office including Word, Excel and PowerPoint

Desired Key Competencies:

  • Hands-on experience and knowledge of FACS, ELISA and cell culture techniques
  • Self-motivated, independently minded, responsive with can-do attitude
  • Positive interpersonal skills with the ability to interact with individuals from a variety of levels/functions
  • Self-organizer, meticulous hands-on habits, keen attention to detail
  • Strong quantitative and analytical skills
  • 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: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Pre-Clinical
Reports To: AD, Nano Platform Development
Status: Exempt

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology. 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 a company with an uncompromising commitment to shared values, a strong work ethic, and respect for individuals. We set clear expectations, empower people to succeed, and reward results. Our executive team, Board of Directors, and investors include several successful industry veterans committed to building an exceptional company capable of transforming the field of immunotherapy.

The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIMTM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. By mimicking natural T cell biology, NexImmune’s T cell product candidates are designed to combine the attributes of cellular precision, potency, and persistence with reduced potential for undesired toxicities.

NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.
For more information, visit www.neximmune.com.

Position Summary:

The Research Associate/Sr. Research Associate in Nano-immunotherapy/Cell Biology will act as a scientific contributor for the Preclinical Immunotherapy and Nanoparticle Platform Development group 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. He/she will be involved in data analysis and interpretation, writing and implementing SOPs, and helping with other work as required by the company, thereby working closely with multiple teams.

Essential Duties and Responsibilities:

  • Perform cell culture of mammalian and animal cell line
  • Isolation and expansion of antigen-specific T cells
  • FACS analysis
  • Perform ELISA, protein assays, cell-based assays, and nanoparticle-based assays
  • Provide support for nanoparticle development for broad clinical applications
  • Write reports, protocols, SOPs. Prepare data summaries and presentations.
  • Order supplies and reagents, maintain inventory records

Education and Experience:

  • BA or MS in Life science (Immunology, Biology, Biochemistry or related field) with 1-3 years of hands-on experience in industry
  • Experience in immunology and T cell biology
  • Experience with mammalian and animal cell culture, sterile techniques
  • Experience with FACS, panel design, and FlowJo
  • Experience with ELISA, protein assays, and other plate reader-based assays
  • Experience with animal models for cancer and/or autoimmune diseases
  • Experience in writing data summaries and preparing scientific presentations
  • Demonstrated proficiency in GraphPad Prism, MS Office including Word, Excel and PowerPoint

Desired Key Competencies:

  • Hands-on experience and knowledge of FACS, ELISA and cell culture techniques
  • Self-motivated, independently minded, responsive with can-do attitude
  • Positive interpersonal skills with the ability to interact with individuals from a variety of levels/functions
  • Self-organizer, meticulous hands-on habits, keen attention to detail
  • Strong quantitative and analytical skills
  • 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: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: PD/MFG
Reports To: MS&T Lead
Status: Full Time / Exempt

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response that mimics natural biology. 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 a company with an uncompromising commitment to shared values, a strong work ethic, and respect for individuals. We set clear expectations, empower people to succeed, and reward results. Our executive team, Board of Directors, and investors include several successful industry veterans committed to building an exceptional company capable of transforming the field of immunotherapy.

The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIMTM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. By mimicking natural T cell biology, NexImmune’s T cell product candidates are designed to combine the attributes of cellular precision, potency, and persistence with reduced potential for undesired toxicities.

NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to at least 3 prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.
For more information, visit www.neximmune.com.

Position Summary:

NexImmune is looking for experienced and highly motivated candidates with an entrepreneurial spirit to join our Protein Process Development and Manufacturing group. We are looking for Scientist/Senior Scientist candidates with an undergraduate, or graduate degree in the life sciences or biochemical engineering along with 7-10 years industry experience in recombinant protein manufacturing, manufacturing sciences & technology, and/or process development with scale-up/technology transfer experience.

We are seeking candidates with experience in process scale-up, document preparation (batch records, material specifications, BOMs, SOPs, process descriptions, technical reports), deviation initiation/investigation and CAPA determination, and person-in-plant. Candidates should also have an understanding of quality and regulatory requirements for early and late phase cGMP manufacturing. Ideal candidates will have hands on process development and/or cGMP manufacturing experience, and an understanding of upstream and/or downstream process science and technology; experience in IND/BLA filing is also a plus.

Candidates must have excellent technical writing, communication, and interpersonal skills.

Essential Duties and Responsibilities:

  • Work with process development SMEs to scale-up processes to internal pilot scale and external CDMO scale.
  • Prepare manufacturing documentation: batch records, material specifications, BOMs, SOPs, process descriptions, technical reports.
  • Work cross-functionally with process development and facilities groups to design and build manufacturing facility/capabilities.
  • Work with manufacturing operators and process SMEs on deviation initiation, investigation, and CAPA determinations.
  • Act as person-in-plant for both internal and external manufacturing.
  • Assist in execution of internal manufacturing runs as needed.
  • Participate in authoring regulatory filings such as INDs, IND amendments, and BLA.

Education and Experience:

  • B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 7 years biotech industry experience in protein manufacturing, manufacturing sciences & technology, and/or process development with scale-up/technology transfer experience.
  • Proven experience in collaborating cross-functionally in a technical environment.
  • 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.
  • Must have excellent communication and writing skills.
  • Must be flexible and able to adapt to changing demands.
  • Positive attitude and interpersonal skills and the ability to work in team-oriented environment are essential.
  • Can coordinate and prioritize parallel tasks.
  • 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

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