Position: Head of Quality Assurance
Reports to: CEO
Location: Cambridge, MA
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.
In addition, Neon has established strategic partners in CRISPR, Merck, and Apexigen to harness opportunities for combination therapies. By the end of 2018, it is anticipated there will be multiple clinical programs utilizing Neon’s platform.
Neon Therapeutics was incubated and launched by Third Rock Ventures and raised a $55M Series A in 2015 and more recently a $106M Series B in December 2017.
The Head of Quality Assurance is responsible for leading and strategically directing the Quality organization and is accountable for the continuous development, execution and administration of a GxP Quality System meeting all compliance requirements with respect to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), ICH and EMA regulations. This will be the first full-time/permanent employee at Neon to exclusively focus on their quality strategy.
The Head of Quality Assurance will develop, maintain, and continually improve Quality Operations, the Quality Management System, the Quality Assurance program, and the Training Program, as well as provide overall Quality and Compliance oversight for the manufacturing and supply chain process support Neon’s personalized medicines.
A successful candidate will embody and demonstrate commitment to Neon’s core values: Patients, People, Science, Tenacity, Pioneer, Integrity
- Lead Quality Assurance function. Build overarching quality strategy for the company to ensure R&D and commercial success is achieved.
- Work in a cross-functional environment to develop personalized products to treat cancer.
- Represent Quality Assurance in company project meetings to ensure adherence to regulatory and compliance requirements.
- Present corporate quality strategy to corporate officers and BOD when appropriate.
- Recommend solutions to complex quality issues and work closely with senior management to resolve significant compliance trends and issues.
- Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
- Manage audit program against GxP standards, FDA/EMA/ICH requirements, and other regulatory standards and ensure timely resolution of any identified issues.
- Implement GCP Quality Assurance programs for clinical trials execution and reporting.
- Quality management of CMOs, contract test laboratories and other vendor services to ensure compliance of manufacture and testing of product.
- Establish and maintain phase appropriate GMP compliance for product manufacture, testing, and stability; ensure appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
- Manage Quality Assurance relationships with GMP service providers; work with CMO QA and technical teams to assess and resolve discrepancies, and noncompliance events to ensure the quality of the product through performance of thorough investigations and risk assessments.
- Review and edit Quality Agreements, provide quality input to project plans, master service agreements and statements of work.
- Review technical and study reports, CMC sections of regulatory submissions, pharmacy manuals, investigator brochures, study protocols and reports, as requested, for compliance with established standards, and regulations.
- Ensure robust planning and execution of documentation for product release.
- Manage Training Program.
Experience and essential skills:
Bachelor’s degree, Master’s degree or PhD in science, pharmaceutical sciences or related field
Minimum 15 years of experience in Quality Assurance with at least 10 years of experience in GMP pharmaceutical development, manufacturing and testing
Proven track record of critical thinking, agility. This includes the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
Thorough knowledge of Phase 1 through Phase 3 product development. Commercial manufacturing and/or large pharma experience a plus. Technical knowledge of analytical method qualification, process validation and establishing product specifications
Preferred experience with personalized medicines and/or gene therapy
Preferred experience with outsourced manufacturing and testing operations with solid understanding of how to onboard new CMOs capable of producing complex therapies
Experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections
Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
Excellent oral and written communication.
Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts.
Proven organizational and leadership skills to mentor and develop team to achieve Company goals. Demonstrated ability to effectively lead professional staff
Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
Must possess excellent organizational and communication skills.
At Neon Therapeutics, our core values drive our actions ever day. Successful candidates will demonstrate and embody our company’s commitment to:
- 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
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.