Postion: Director GMP
Reports to: QA Head of Quality
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.
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.
The GMP QA position will be responsible for quality oversight of manufacturing operations at CMOs. Responsible for material disposition, vendor management and qualification, validation, certificates of analysis, and stability assessments. Develop, implement and maintain GMP quality assurance (QA) systems and activities for assigned projects. Review of documents used in Good Manufacturing Practices (GMP) and for regulatory submissions for drug products.
Key Competencies for Success:
Ethics -Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to
succeed. Contributes to building a positive team spirit; Shares expertise with others.
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.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Uses intuition and experience to complement data.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively.
Technical Skills – Assesses own strengths and development areas; Shares expertise with others.
Dependability – Takes responsibility for own actions; Keeps commitments.
- Quality oversight of contract manufacturing operations for clinical trial materials. Includes review and approval of change control requests to ensure the proposed changes are justified, supported by data and have been appropriately validated where applicable.
- Oversee and monitor Quality Assurance processes with focus on master production and control records to ensure that production and control operations are adequately defined and that good manufacturing practices are utilized for the manufacture of drug substances and drug products at CMOs
- Responsible for material disposition of clinical trial materials to support clinical operations includes certificate of analysis generation.
- Responsibility for Vendor Management of early to late phase development GMP Quality function to ensure appropriate and timely vendor qualification and oversight.
- Generate, reviews and approval of the Validation Master Plan and Validation Protocols, executed protocols, and summary reports at both Neon and CMOs.
- Performs technical assessments and QA approval of deviation and OOS investigations for clinical products.
- Participate and/or Conduct Risk Assessment and / or Failure Mode and Effects Analysis activities for both Design and Process FMEA’s.
- Participate in Material Review Board- recommend disposition and corrective action.
- Defines and implements as appropriate quality standards, systems, and metrics for clinical manufacturing and quality operations.
- Compiles, organizes, and presents metrics for areas of responsibility to senior management.
- Participates in preparation for and execution of regulatory audits. Ensures audit observations are addressed appropriately and completed on schedule.
- Ensures internal compliance with Title 21 CFR Part 11 and relevant global computerized system regulations for document management and related GxP computerized systems.
- Manage review of product release and stability data, support method transfers and validations.
- Provide quality support on technology transfers.
- Support Quality Management Reviews and periodic product reviews
Experience and Essential Skills
- BA/BS in Chemistry or life sciences (Biology, Pharmacology, etc.), or Chemical Engineering preferred.
- Minimum 1 O+ years of experience in the pharmaceutical or biopharmaceutical industry required with increasing levels of responsibility. 5+ years relevant experience in a Quality function (QA) is also required or an equivalent combination of education and experience.
- Thorough understanding of quality management systems and quality system practices in the pharmaceutical industry.
- Experience with CMO Vendor management/Quality Systems/ aseptic processing required.
- Computer System validation experience preferred
- Experience implementing and managing cGMP quality systems, including Change Control, Validation, Material disposition, Certificates of Analysis, Stability monitoring and Specifications. Expert knowledge of FDA, EU, ICH, ISO requirements for GXP areas.
- Ability to lead and work with others, including CMOs.
- Demonstrated ability to work in a multi-disciplinary setting acting as facilitator.
- Ability to travel 15-20%.