Position: QA Manager, Research and Development
Reports to: Head of Quality
Location: Cambridge, MA
Neon Therapeutics is an immuno-oncology company focused on developing novel therapeutics leveraging neoantigen biology to treat cancer. Neon 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 partnerships with CRISPR, Merck, and Apexigen, among others. 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, Raised a $55M Series A in 2015, a $106M Series B in December 2017, and completed its IPO, raising $100M in the summer of 2018.
Supporting the development, validation and transfer of robust formulations, manufacturing processes and analytical methods. Designing, implementing and enabling processes/practices such as R&D stage gate deliverables, development standards, acceptance criteria, etc. within various areas of R&D. Building talent, skills, and competencies needed within R&D Quality to support Developmental R&D and ensuring that the group delivers value and gain acceptance with R&D while capabilities are being built.
Partners with R&D to assure formulations, manufacturing processes, and analytical methods are adequate and justified prior to transfer to manufacturing sites. Assures the completeness and accuracy of Product Development Reports and Technology Transfer Dossiers. Sustains substantial compliance of quality operations at R&D sites and subcontract R&D facilities. Works with R&D to jointly design, implement, and sustain enabling processes, such as R&D stage gate deliverables/acceptance criteria and development standards. Supports identification, due diligence and approval of new, third‐party R&D partners in conjunction with Regional Quality.
Provides support to Quality Audit team during audits of R&D facilities. Ability to travel domestically and internationally as needed.
Key Responsibilities & Features:
Provides QA oversight of product development and technical services teams to ensure execution of the program as per GxP principles
Support of technical transfers and training of staff to ensure robust product transfers- Monitoring of study raw data and report review. Monitoring of overall document management system and raw data recording system. Study protocol, quality system documents approval.
Review and provide feedback for new therapeutic candidates related to Quality Target Product Profile (QTPP), Specifications including Critical Quality Attributes (CQAs), analytical methods, contribute to defining the process control strategy (PCS), Stability data review and assessment
Training and assessment of training for technical transfers to CMO.
Review and Approval of event/incident investigation, deviation, OOS and change control system at CMOs.
Stay informed of cGMP trends as well as current and new regulatory requirements. Perform other duties as assigned.
Understanding regulations and requirements of different countries and decision making without compromise on Quality. Understanding the intricacies of product and process development. Coordination with technical team of R&D Leaders and Scientists.
Key Competencies for Success:
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively.
Experience and Essential Skills:
- Minimum of Master’s in Chemistry or Pharmaceutical Sciences Experience
- Minimum 10+ years of pharmaceutical industry experience, preferably in both Pharmaceutical Development & Quality Assurance or a PhD and 5 years’ experience in Pharmaceutical Development
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.