Senior Research Associate, Quality Control

POSITION SUMMARY

The GreenLight team is looking for a high-performing, self-motivated individual who works well in a fast-paced environment in a leading-edge biotech company. This role is an exciting opportunity to support development of new LNP-mRNA vaccine candidates to help advance the company’s pipeline and RNA platform technology. Reporting directly to the QC Laboratory Manager, the individual will be a key contributing member of the team assisting in establishing new workflows, leading documentation efforts, and focusing on GMP manufacturing activities. The position will support the qualification of analytical test methods, release of production materials, and stability testing and reporting of mRNA vaccines and other RNA based therapeutics. The ideal candidate will have expertise in HPLC and bioanalytical test methods to enable analytical testing needs within the QC laboratory.

MAJOR RESPONSIBILITIES

• Maintain and improve QC laboratory systems used to support the development and manufacture of RNA-based products intended for use in humans, including equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training.
• Support the analytical control strategy for raw material release by maintaining proper documentation, working with vendors and CROs, and confirming specifications are met.
• Manage GMP stability study reports for multiple vaccine clinical development programs by performing stability / batch data trending per ICH Q5C.
• Perform cGMP analytical testing for release and stability using HPLC, CE, qPCR and ELISA
• Review and evaluate raw data (peer review level).
• Author and review SOPs/Forms and technical reports.
• Initiate and own laboratory deviations/CAPAs and support investigations (OOS), performing assessment, authoring protocols/reports and investigation closure.
• Author, review, and execute equipment validations.
• Execute phase-appropriate test method validation protocols, conduct validations, and issue validation reports.
• Participate in providing the necessary information for regulatory filings and inspections.
• Participate in audits (internal and external) and in remedial actions for any non-compliance.
• Collaborates with internal and external stakeholders and partners to ensure that regulatory agency quality assurance requirements are met.  
• May assist with auditing Contract Research Organizations as well as assist with hosting regulatory agency (e.g., FDA) inspections.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

• Strong working knowledge of HPLC methodologies including basic troubleshooting. Previous experience with Agilent Openlab considered a plus.
• Hands-on experience working with analytical methods such as: HPLC, CE, qPCR, and ELISA.
• Previous experience with mRNA considered a plus.
• Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude.
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.
• Knowledge of applicable GMP regulations, ICH & FDA guidelines, USP, and other applicable regulatory guidances (US and EU).
• Ability to succeed in a team-oriented environment under very dynamic conditions. Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.
• ELN and LIMS experience preferred

 EDUCATION

• Bachelor’s degree with 6-8 years, or MS 5+ years in a biotechnology discipline.
  1-2 years of experience in a cGMP/GxP environment is preferred.