Head, Protein Process Development & Mfg

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 (AIM^TM) 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 diseases.

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 of 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 an 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 the 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 of 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 the 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 functions.
• 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.

NexImmune is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Recruitment & Staffing Agencies: NexImmune does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Vertex or its employees is strictly prohibited unless contacted directly by NexImmune’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of NexImmune, and will not owe any referral or other fees with respect thereto.

Company policy requires that all employees be fully vaccinated against COVID-19, and all new hires must be fully vaccinated by the time they start employment. The Company will make reasonable accommodations to its vaccination policy in accordance with applicable law for those individuals who cannot become vaccinated because of a disability, pregnancy, or a sincerely held religious belief, practice, or observance.