Careers

MANAGER – SENIOR MANAGER, QUALITY CONTROL at Neon Therapeutics
Cambridge, MA, US

Position:                       Manager/Senior Manager, Quality Control
Reports to:                  Vice President, Technical Operations
Location:                      Cambridge, MA

Company Summary

Neon Therapeutics is an immuno-oncology company focused on developing novel therapeutics leveraging neoantigen biology to treat cancer.  The Company utilizes its expertise in bioinformatics, neoepitope prediction and immune monitoring to identify tumor specific mutations and monitor clinical response to their personalized vaccines.  Neon Therapeutics’ lead program is NEO-PV-01, a bespoke neoantigen vaccine that builds upon years of research and development at the Broad Institute and Dana-Farber Cancer Institute.  NEO-PV-01 is now being studied in a Phase 1b clinical trial combining the vaccine with Opdivo®, a PD-1 immune checkpoint inhibitor from Bristol-Myers Squibb, in patients with measurable metastatic melanoma, non-small cell lung cancer and bladder cancer.  Also in development are NEO-PTC-01, a bespoke autologous T cell therapy, and a Shared Neoantigen Program leveraging neoepitopes that are common across patients and tumor types.

Neon Therapeutics was incubated and launched by Third Rock Ventures, and raised a $55M Series A in 2015 and more recently a $70M Series B in December 2016.

At Neon, our core values act as a guidepost for our thoughts and behaviors:

  • Patients: Urgently develop life-changing medicines
  • People: Listen/Learn/Teach
  • Science: Creative/Rigorous/Uncompromising
  • Tenacity: Persevere/Build Neon to last
  • Pioneer: Leave the comfort zone/Create the future
  • Integrity: Do RIGHT

Position Summary

Neon is seeking a highly-motivated Quality Control manager with a strong chemistry and microbiology background to join Neon’s Technical Operations group. The candidate will manage quality control of Neon’s clinical supply production at contract manufacturing and testing organizations.  The candidate will work in close collaboration with the Manufacturing, Supply Ops, Peptide Chemistry and Quality Assurance groups at Neon to support continual improvement and cGMP compliance. He/she will work independtly as well as part of a multi-disciplinary teams to support the development and approval of our clinical development programs.

Responsibilities

  • Manage the quality control of clinical products in accordance with strict timelines and budget
  • Work with Neon’s Protein Chemistry group to oversee the transfer and qualification of test methods to contract manufacturers
  • Manage the stability program and retest/expiry dating
  • Lead the development of material specifications
  • Work closely with supply operations and quality assurance to ensure cGMP compliance and meet release schedules
  • Develop, manage and report quality control metrics
  • Participate and contribute to department strategy, goals and budgets

Experience and essential skills:

  • BS or MS in Chemistry or Life Sciences with 5+ years of industry experience and 2+ years in supervisory/management role
  • Extensive cGMP experience
  • Expert in analytical chemistry, microbiological methods, and methods validation
  • Extensive experience managing cGMP contract testing labs
  • Expertise in drug stability and associated statistical analysis
  • Experience in cell therapeutics a plus
  • Strong leadership and project management skills
  • Proficiency in problem solving and leading investigations
  • Excellent communication and collaboration skills
  • Ability to work within cross-functional teams
  • Attention to detail and highly organized

Equal Employment Opportunity

Neon Therapeutics provides equal employment opportunities to all employees and applicants for employment without regard to race, color, national origin, religion, sexual orientation, gender, gender identity or expression, age, veteran status, disability, or genetics. In addition to federal law requirements, Neon Therapeutics complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.