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: Regulatory
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:

NexImmune is looking for an outstanding leader to champion their regulatory efforts for their business. This individual will have extensive experience and in-depth knowledge of US regulatory requirements This individual will be responsible to design and develop processes which would ensure that every product meets federal regulatory requirements.

Essential Duties and Responsibilities:

  • Establish leading edge regulatory strategies to effectively navigate the current environment, anticipate future changes supporting the development of our novel AIM platform, Cell Therapy and injectable products.
  • This position is the primary liaison and represents the Company to FDA and related health authorities. This position establishes productive working relationships with the US Regulatory authorities to assure a current understanding of all applicable laws, regulations, guidance’s, etc. This position also provides guidance to the company on the current regulatory environment related to our biologics (toolkit), nanoparticles and cell therapies addressing specific issues and information requests with the agency. Oncology experience preferred.
  • Oversee/coordinate the preparation/completion of documents for submission to US regulatory authorities including new IND’s, DMF’s and future BLA’s as well as the preparation of supplemental applications and amendments and maintenance.
  • Oversee/coordinate preparation of information and related activities for meetings with drug regulatory agencies as well conduct of meeting and preparation of accurate meeting minutes
  • Oversee/coordinate/review the collection/preparation/submission of pharmacovigilance information and safety reports.
  • Responsible for supporting due diligence activities associated with business development.
  • Maintain a detailed knowledge of FDA regulations, guidelines, and standard procedures for biologics, cell therapies and injectable therapeutic vaccines
  • Oversee the preparation of periodic progress reports as required
  • Ensure appropriate labeling for clinical products and future approved products
  • Build and manage the regulatory department to support the platform and clinical development.
  • Perform other duties as assigned.

Education and Experience:

  • BA, MS, or PhD in physical, pharmaceutical, biological, or other life science plus direct CMC FDA submission experience. Advanced degree preferred.
  • A minimum of 15 years of hands-on regulatory experience, with 8-10 years in a management role. Further, with a successful record of submissions and approvals of BLA’s and sBLA applications to the FDA.
  • A history of extensive interaction with the Office of Tissue, Cellular and Gene Therapies and CBER; experience with fast track and priority review designations.
  • Experience with international product regulations in preparing regulatory strategy and submissions for registering products is helpful, but not required
  • Demonstrated know-how in developing clinical trial designs necessary for IND/BLA products requiring clinical studies
  • Excellent written and verbal communication skills are required, as well as experience working as part of cross-functional, multinational teams.
  • The individual should be comfortable interacting with a diverse group of professionals and be able to think “out of the box”; as well as with contributing on projects (including those outside of their direct responsibilities) as part of contributing to the Company’s overall success.
  • Needs to be culturally adaptive and have demonstrated leadership qualities as well as a successful track record in diverse environments.
  • Needs to have energy and drive with an entrepreneurial approach based on a global perspective.

 Qualification Requirements:

  • Excellent written and verbal communication skills are required, as well as experience working as part of cross-functional, multinational teams. This is a newly created, highly visible, and critical role in the company. The individual should be comfortable interacting with a diverse group of professionals and be able to think “out of the box”; as well as with contributing on projects (including those outside of their direct responsibilities) contributing to the Company’s overall success.

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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Clinical
Reports To: CMO
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:

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: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: PD
Reports To: COO
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.

The VP of CMC fulfills a critical and highly visible role as a key strategist and team member in NexImmune’s Sr. Leadership Team. He/She will establish and oversee pharmaceutical development strategy and tactical implementation plans for phase-appropriate formulation and manufacturing deliverables.

Essential Duties and Responsibilities:

  • Serve as discipline head for CMC, responsible for building the internal CMC function and identifying and managing key external CMO partners
  • Work with Regulatory, QA and senior management to develop, refine and ensure compliance with GMP and relevant regulations.
  • Effectively manages multiple vendors.
  • Maintains knowledge of current best manufacturing practices and regulatory guidances and regulations.
  • Lead preparation/content development of FDA and international regulatory filings in collaboration with Regulatory and Quality.
  • Oversee all manufacturing operations, including review and approval of master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as scope of work (SOWs) with CMOs.
  • Communicate effectively, build relationships and actively partner with other discipline heads and CMOs, vendors, analytic laboratories and consultants.
  • Responsible for development and oversight of scale-up and analytical testing of drug substance (API) and drug product (DP) production for preclinical safety/clinical testing and commercialization.

Education and Experience:

  • PhD or equivalent in Biochemistry, Protein Science, Chemical Engineering, or related Life Science discipline, preferred. MS with extensive industry experience in manufacturing/CMC will be considered. • 15+ years’ experience in manufacturing in the biotech or pharmaceutical industry.
  • Extensive experience with the development, optimization and scale-up of manufacturing processes for biologic therapeutics. Formulation development expertise highly desired.
  • Experience with therapeutic proteins desired.
  • End to end drug development and commercialization experience, with prior experience leading the CMC discipline thorough successful BLA or NDA submissions and approvals, product launch and commercial stage manufacturing and supply chain.
  • Prior experience in managing multiple functions such as upstream/downstream process development, analytical & formulation development.
  • Hands on experience in oversight and management of CMC activities at CMOs and partner facilities.
  • Ability to set up supply chain strategy while being technically competent to collaborate internally and with outside vendors on multiple process development issues.
  • Strong analytical and problem-solving skills, with ability to ‘troubleshoot’ in all areas of CMC.
  • Solid understanding of FDA and EMA regulatory guidelines/requirements as well as experience with authoring regulatory submissions. Demonstrated ability to represent the company at regulatory meetings.
  • Thorough knowledge of GMP requirements, and basic familiarity with GLP/GCP.
  • Experience in the implementation of GMP QMS, quality oversight/release requirements in US and EU, root cause analysis, and CAPA implementation. Continuous improvement and Six Sigma training and mindset are highly desirable.
  • Excellent interpersonal, organizational, negotiation and communication (verbal and written) skills are essential.
  • Ability to think, plan, and influence strategically and diplomatically on the process development priorities across multiple projects is necessary.
  • Leadership and management experience essential with proven ability to build a team, coach and motivate employees, set priorities, and effectively make decisions.

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.

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.

 Qualifications:

  • 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

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Clinical
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 Summery:

Reporting to the Chief Medical Officer, the Head of Drug Safety will be responsible for leading the pharmacovigilance function, providing leadership and clinical support to drug safety data management and interpretation and risk management activities for NexImmune, Inc., including oversight of clinical trial Serious Adverse Event (SAE) processing and safety data analysis to support signal detection and risk/benefit profile evaluation. This individual will ensure timely, consistent, and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs).

Essential Duties and Responsibilities:

  • Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
  • Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment, clinical trial data interpretation, and medical review of individual case reports of serious adverse events
  • Address safety-related topics as a member of the Clinical Leadership Team
  • Work with Clinical Scientist on safety monitoring and assessment activities, including:
    • Providing input for responses to regulatory agency questions and questions from IRBs and Ethics Committees, with respect to safety/pharmacovigilance activities and safety data
    • Acting as the point of contact accountable for setting up and running DSMBs
    • Investigator’s Brochure/informed consent updates
    • Setting up and acting as chair for safety data review meetings
    • Participating in routine safety cohort reviews for ongoing phase 1 dose escalation studies
    • Event coding and database reconciliation
  • Constant evaluation of the effectiveness of the Drug Safety system
  • Communicate recommended changes to Drug Safety system changes to assure:
    • Compliance with safety data management and reporting requirements in all relevant territories
    • Optimized safety database ownership and access for safety monitoring, signal detection and reporting
    • Effective SOPs are in place
    • Strong safety vendor governance
  • Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance at NexImmune to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File
  • Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
  • Lead the development of and review DSURs with NexImmune Medical Directors/Clinical Scientists
  • Review safety sections on cross-functional documents, including study protocols, study reports, and regulatory reports
  • Ensure audit and inspection readiness of the function at all times

Education and Experience:

  • MD required. Minimum of 7 years in Drug Safety related activities in pharma/biotech preferred
  • Demonstrated leadership abilities or oversight roles
  • Clinical trial experience
  • Experience authoring, reviewing, and providing input to drug-safety related regulatory report
  • Successful involvement in regulatory agency interactions or inspections
  • Good knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk management
  • Medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring highly desirable and strongly preferred
  • Computer knowledge, including Microsoft Office, Windows, and familiarity with safety database use
  • Excellence in oral and written communications with attention to detail.

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 looking for qualified candidates with a Ph.D. degree in Genetics/ Biochemistry. Candidates must be broadly trained in T cell therapy/molecular biology/genomics/ protein process development and bioinformatics techniques, including, genomic data analysis and interpretation, DNA sequence analysis, cell line development, R&D level protein process development.  Knowledge of T cell engineering especially TCR analysis assays 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.  The candidate must have deep understanding of diverse analytical techniques to support protein process development and T cell Therapy projects, including ELISA, SDS-PAGE, qRT-PCR, NGS, Immuno-seq and HPLC.

Essential Duties and Responsibilities:

  • Lead role in R&D level process development, scale up and technical support for manufacturing of proteins, including management of 1+ direct report.
    • Manage workflows with external collaborators until completion of the study.
    • Lead the study and demonstrate proficiency in various analytical methods to determine protein physico-chemical properties, activity, identity, stability, purity, etc. in support of R&D process development.
    • Optimize processes to ensure consistent, high-yielding, and scalable method to generate materials for pre-clinical studies.
    • Generate, manage, review, and maintain critical data, providing reports for assessments by senior management.
    • Communicate with various departments; Pre-clinical, Clinical, Process Development, Analytical, Manufacturing and QA/QC.
    • Knowledge on Standard Operating Procedures, quality, and regulatory requirements such as FDA compliance.
  • Lead Genomics and Bioinformatics capability to support preclinical and clinical T cell therapy.
    • Develop a science, technology, and improvement vision for the use of Genomics and Bioinformatics methods in T cell therapy (e.g., TCR immune seq assay analysis).
    • Design and manage internal workflows, perform quick and thorough analyses of DNA sequencing of T-cell receptors and other clinical data to understand confounders, make descriptive figures, and address key scientific questions.
    • Collaborate with data scientists and computational biologists to align effective areas of focus.
    • Manage workstreams with external collaborations and alliances (Developing SOW, PO, shipping, billing data tracking).
    • Develop and maintain integrated project plans (internal program trackers, project timeline tracker and databases) to identify/communicate interdependencies as well as critical path activities across multiple programs.
    • Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with the various R&D projects, as well as ensure teams are aware of current integrated program timelines.
    • Facilitate project team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of objectives.
    • Knowledge on Standard Operating Procedures, quality, and regulatory requirements such as FDA/IND compliance.

Education and Experience:

  • Ph.D. in Genetics/ Biochemistry with a minimum of 10 years’ experience in scientific and leadership roles preferably within biopharma/Immuno-oncology companies.
  • Experience in genomics, bioinformatics, T cell therapy and protein process development projects.
  • Detailed knowledge of cellular and/or tumor immunology principles (including T-cell therapy and TCR immune-seq assay) and technologies, and relevant experimental techniques (e.g., cell culture, T-cell activation protocols, flow cytometry, in vitro cellular assays, etc.)
  • Excellent time management and proven ability to complete projects on time.
  • Excellent level of initiative and quest for knowledge.
  • Demonstrated proficiency in Computational data analysis tools, 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 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: careers@neximmune.com

NexImmune Inc.
Gaithersburg, Maryland
www.neximmune.com

Department: Clinical Ops
Reports To: CMO
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.

The Clinical Research Scientist (CRS) works closely with the Clinical Research Physician and is responsible for contributing scientific insight and expertise in clinical trial design, statistics, pharmacodynamics and pharmacokinetics to support clinical research projects. The CRS is expected to work collaboratively with other study team members including but not limited to Clinical Operations, Data Management, Statistics, Drug Safety, and Regulatory. Limited travel required as needed to support clinical programs.

Responsibilities will include, but are not limited to, the following:

  • Prepare study protocols and informed consent documents This includes writing, reviewing, amending and facilitating cross-functional review as appropriate. Collaborate with Key Opinion Leaders as required.
  • Contribute to CRF development, review of data management deliverables (edit checks, CRF completion guidelines, etc.)
  • Review and understand Statistical Analysis Plan; review and contribute to development of tables, listing and graphs
  • Contribute to the Clinical Development Plan (CDP).
  • Assist the Medical Monitor (MM) to make recommendations, take action and provide clinical research expertise related to projects.
  • Interface collaboratively with study team members, e.g., Clinical Operations, Data Management, Statistics, Drug Safety, and Regulatory
  • Along with the Study Team, provide relevant support to CRO in the management of clinical studies.
  • Actively participate and contribute to study/project team meetings; may represent Medical monitor at study team meetings when appropriate.
  • Review scientific literature related to assigned clinical programs.
  • Provide scientific expertise to other departments and line functions.
  • Review and interpret study data as it relates to efficacy and safety.
  • Provide scientific input, review, and edits to clinical study reports, Investigator Brochures, narratives, INDs, NDAs, briefing documents, annual reports, and other regulatory submissions. May be called to assist in writing these documents.
  • Organize and provide training assistance to departments/vendors (scientific/development improvements).
  • Serve as a liaison with internal/external scientific and medical experts to ensure protocol execution is consistent with intent. Coordinate and oversee medical or endpoint-specific training for study protocols.
  • Assist with planning of, and participate in, Investigator Meetings and Advisory/Scientific boards. Prepare and present clinical data in these venues as needed.
  • Assist with budget projections for clinical activities (such as consultants, advisory board meetings, etc.) for assigned clinical programs.
  • Prepare Data Monitoring Committee (DMC) and/or adjudication charters. Prepare deliverables and participate in periodic review meetings.

Skills/Knowledge Required:

  • 5-7 years of biotech/pharma/CRO experience with at least 3 years in clinical research and development.
  • Bachelor’s degree required with a concentration in life science preferred. Masters degree, PhD or Pharm D. or equivalent preferred.
  • medical/scientific writing skills
  • medical/scientific and clinical research knowledge
  • analytical and influencing skills
  • Ability to interpret data
  • understanding of global clinical study design and drug development processes
  • Knowledge of GCP and ICH Guidelines
  • Ability to work as part of a team
  • Good presentation skills
  • Detail-oriented, well-organized
  • Able to work independently, exercise sound judgment, and escalate issues when necessary

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

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 master’s 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 critically, 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.

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